PENTAX of America, Inc.
Montvale, NJ, US
PENTAX of America, Inc. appears in FDA device records in Montvale, NJ. FDA records list 72 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 64 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to PENTAX of America, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- C2 Therapeutics, Inc.510(k), enforcement report, recall
- Pentax Medicalregistration, 510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 72FDA records hold 72 510(k) clearances for PENTAX of America, Inc. between 2004 and 2025. The busiest year on record is 2019, with 10. The most recent is 2025, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 4 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 4 |
| 2014 | 4 |
| 2015 | 5 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 8 |
| 2019 | 10 |
| 2020 | 4 |
| 2021 | 7 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 5 |
| 2025 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) | FDS | Substantially Equivalent | |
| K251127 | PENTAX Medical Video Processor (EPK-i8020c) | PEA | Substantially Equivalent | |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | FDF | Substantially Equivalent | |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) | FDS | Substantially Equivalent | |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) | FDT | Substantially Equivalent | |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | GEH | Substantially Equivalent | |
| K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | EOQ | Substantially Equivalent | |
| K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock | EOQ | Substantially Equivalent | |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14 | ODC | Substantially Equivalent | |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL | PEA | Substantially Equivalent | |
| K213235 | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System | EOQ | Substantially Equivalent | |
| K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | EOX | Substantially Equivalent | |
| K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 | EOB | Substantially Equivalent | |
| K212814 | C2 CryoBalloon Ablation System | GEH | Substantially Equivalent | |
| K210928 | PENTAX Medical Video Bronchoscope EB11-J10 | EOQ | Substantially Equivalent | |
| K210177 | PENTAX Medical Video Upper GI Scopes EG17-J10 | FDS | Substantially Equivalent | |
| K212201 | PENTAX Medical Auto Leakage Tester SHA-P6 | PCV | Substantially Equivalent | |
| K210485 | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) | FDS | Substantially Equivalent | |
| K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2 | FDT | Substantially Equivalent | |
| K202365 | Pentax Medical Video Duodenoscope ED32-i10 | FDT | Substantially Equivalent | |
| K203166 | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | ODG | Substantially Equivalent | |
| K203024 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge | GEH | Substantially Equivalent | |
| K200678 | PENTAX Medical Video Bronchoscope EB-J10 Series | EOQ | Substantially Equivalent | |
| K200090 | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) | ODG | Substantially Equivalent | |
| K190805 | PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL | PEA | Substantially Equivalent | |
| K192245 | Pentax Medical Video Duodenoscope ED34-i10T2 | FDT | Substantially Equivalent | |
| K190799 | PENTAX Medical Video Upper GI Scopes (EG Family) | FDS | Substantially Equivalent | |
| K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | PEA | Substantially Equivalent | |
| K192280 | PENTAX Medical ED-3490TK Video Duodenoscope | FDT | Substantially Equivalent | |
| K183516 | PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | EOQ | Substantially Equivalent | |
| K183691 | PENTAX Medical ENT Video Imaging System | EOB | Substantially Equivalent | |
| K183654 | PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus | EOQ | Substantially Equivalent | |
| K181084 | PENTAX Video Colonoscopes (EC Family) | FDF | Substantially Equivalent | |
| K182846 | PENTAX Medical EPK-3000 Video Imaging System | EOB | Substantially Equivalent | |
| K182004 | PENTAX Medical Endoscopic Ultrasound System | ODG | Substantially Equivalent | |
| K171011 | PENTAX Medical VIVIDEO ENT Videoscope Solution | EOB | Substantially Equivalent | |
| K181522 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope | FDT | Substantially Equivalent | |
| K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | PEA | Substantially Equivalent | |
| K172156 | PENTAX Medical EPK-3000 Video Imaging System | EOB | Substantially Equivalent | |
| K161222 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope | FDT | Substantially Equivalent | |
| K163684 | C2 CryoBalloon Ablation System | GEH | Substantially Equivalent | |
| K173554 | PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope | EOQ | Substantially Equivalent | |
| K163614 | PENTAX Medical ED34-i10T, Video Duodenoscope | FDT | Substantially Equivalent | |
| K162151 | PENTAX Medical ENT Video Imaging System | EOB | Substantially Equivalent | |
| K162447 | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner | ODG | Substantially Equivalent | |
| K161202 | C2 Cryoballoon Ablation System | GEH | Substantially Equivalent | |
| K160994 | C2 CryoBalloon Focal Pear Catheter | GEH | Substantially Equivalent | |
| K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System | GEH | Substantially Equivalent | |
| K153541 | Coldplay CryoBalloon® Ablation System | GEH | Substantially Equivalent | |
| K150618 | PENTAX Medical EPK-i7010 Video Processor with GI Family | PEA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2518897 | 1000080301 | PENTAX of America, Inc. | 3 Paragon Drive, MONTVALE, NJ 07645 US | 2026 | and 26 more, listed in full below |
| 3012414760 | 3012414760 | Pentax Medical | 6715 Millcreek Drive, Unit 1, Mississauga Ontario L5N 5V2 CA | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEBAccessories, Cleaning, For Endoscope
- NZAAccessories, Germicide, Cleaning, For Endoscopes
- FOBBedpan
- FCGBiopsy Needle
- EOQBronchoscope (Flexible Or Rigid)
- FCYBulb, Inflation, For Endoscope
- KQMCamera, Surgical And Accessories
- FWGCamera, Television, Endoscopic, With Audio
- FWFCamera, Television, Endoscopic, Without Audio
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- FLGCleaner, Ultrasonic, Medical Instrument
- FDFColonoscope And Accessories, Flexible/Rigid
- FAJCystoscope And Accessories, Flexible/Rigid
- LMBDevice, Digital Image Storage, Radiological
- FDTDuodenoscope And Accessories, Flexible/Rigid
- KLXElectroglottograph
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- ODCEndoscope Channel Accessory
- PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- OCXEndoscopic Irrigation/Suction System
- PCVEndoscopic Leak Tester
- ODGEndoscopic Ultrasound System, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- EOXEsophagoscope (Flexible Or Rigid)
- FDSGastroscope And Accessories, Flexible/Rigid
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- GCJLaparoscope, General & Plastic Surgery
- EQLLaryngostroboscope
- FCWLight Source, Fiberoptic, Routine
- OUGMedical Device Data System
- KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube
- EOBNasopharyngoscope (Flexible Or Rigid)
- FEQPump, Air, Non-Manual, For Endoscope
- MEDSterilant, Medical Devices
- LMDSystem, Digital Image Communications, Radiological
- NEZSystem, Imaging, Gastrointestinal, Wireless, Capsule
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
- GCWTransformer, Endoscope
- GEHUnit, Cryosurgical, Accessories
- JRJUnit, Drying
- BZDVentilator, Non-Continuous (Respirator)
- NVEWasher, Cleaner, Automated, Endoscope
Recall records
Showing 25 of 64| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2329-2025 | Pentax Medical Video Processor; Model Number: EPK-i8020c; | During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane. | Class II | Open, Classified | |
| Z-1238-2025 | Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes. | Class II | Open, Classified | |
| Z-1237-2025 | PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes. | Class II | Open, Classified | |
| Z-1236-2025 | PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the patient's mucous membranes. | Class II | Open, Classified | |
| Z-2449-2021 | Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families | Class II | Open, Classified | |
| Z-2448-2021 | Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families | Class II | Open, Classified | |
| Z-1682-2021 | Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2. | IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result in unforseen events such as mucosal injury, lacerations, or bleeding of the patient. Detachment of the distal end cap (OE-A63) into the oral cavity of the patient may also result in aspiration | Class II | Terminated | |
| Z-0293-2021 | 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs. | Class II | Terminated | |
| Z-0292-2021 | 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs. | Class II | Terminated | |
| Z-1268-2020 | Pentax Video Colonoscope Model: EC38-i10L | Distributed in the USA without an approved 510K | Class II | Terminated | |
| Z-1267-2020 | Pentax Video Colonoscope Model: EC34-i10L | Distributed in the USA without an approved 510K | Class II | Terminated | |
| Z-1327-2019 | Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide. | Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller. | Class II | Terminated | |
| Z-1326-2019 | Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide. | Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller. | Class II | Terminated | |
| Z-1325-2019 | Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. The system includes the following components: (1) CryoBalloon Catheter connects to the Controller, which controls the operation of the Catheter such as diffuser (sprayer) positioning and ablation (nitrous oxide release); (2) CryoBalloon Controller contains the cartridge heater and cryogen delivery valve, which is controlled with the foot pedal; (3) Foot Pedal; and (4) CryoBalloon Cartridge containing 36 grams of nitrous oxide. | Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller. | Class II | Terminated | |
| Z-0970-2019 | C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. | The Controller does not detect overpressure in the balloon during the application of non-dosing puffs of Nitrous Oxide, which can contribute to balloon over pressurization, if the intended vent lumen of the catheter is significantly occluded to prevent relieving balloon pressure due to a kinked catheter condition.If a patient is exposed to higher than physiologic pressures, adverse events such as perforation or mucosal laceration may occur. | Class II | Terminated | |
| Z-2256-2018 | C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications. | The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the controller in the detach orientation. In this orientation, the catheter is not securely attached to the controller and may be partially (~1cm) ejected from controller. | Class II | Terminated | |
| Z-0643-2018 | Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic, and cystic ducts. | The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy. | Class II | Terminated | |
| Z-0615-2018 | Video Cystoscope models ECY-1570 and ECY-1570K | The video cytoscopes lack 510(k) premarket notification clearance. | Class II | Terminated | |
| Z-3068-2017 | Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum. | Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step. | Class II | Terminated | |
| Z-3067-2017 | Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum. | Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step. | Class II | Terminated | |
| Z-2745-2017 | 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications. | Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems. | Class II | Terminated | |
| Z-2744-2017 | 9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications. | Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems. | Class II | Terminated | |
| Z-2743-2017 | 9310HD Digital Video Capture Modules Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications. | Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems. | Class II | Terminated | |
| Z-2742-2017 | 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications. | Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems. | Class II | Terminated | |
| Z-2713-2017 | Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts. | Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain