Medivators Inc
Conroe, TX, US
Medivators Inc appears in FDA device records in Conroe, TX. FDA records list 46 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Medivators 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.
- Minntech Corp.510(k), recall
510(k) clearance history
FDA records hold 46 510(k) clearances for Medivators Inc between 1987 and 2023. The busiest year on record is 1994, with 6. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 3 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 3 |
| 1994 | 6 |
| 1995 | 3 |
| 1996 | 2 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 3 |
| 2002 | 1 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 3 |
| 2017 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231418 | ENDOGATOR™ Hybrid Irrigation Tubing | OCX | Substantially Equivalent | |
| K223040 | Endo SmartCap | FAJ | Substantially Equivalent | |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid | FEB | Substantially Equivalent | |
| K172677 | Advantage Plus Pass-Thru | FEB | Substantially Equivalent | |
| K162128 | Scope Buddy Plus Endoscope Flushing Aid | FEB | Substantially Equivalent | |
| K160846 | AmplifEYE | FED | Substantially Equivalent | |
| K152394 | Rapicide PA High-Level Disinfectant Test Strips | JOJ | Substantially Equivalent | |
| K151522 | DEFENDO Bronchoscopy Suction Valve | KTI | Substantially Equivalent | |
| K133724 | MINNCARE HD | NIH | Substantially Equivalent | |
| K140753 | ENDO SMART BOTTLE, RINSE AND INSUFFLATION SYSTEM | OCX | Substantially Equivalent | |
| K120306 | RAPICIDE OPA-28 | MED | Substantially Equivalent | |
| K092387 | MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM | FEB | Substantially Equivalent | |
| K071298 | HF JUNIOR HEMOFILTER | KDI | Substantially Equivalent | |
| K050952 | HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR | KDI | Substantially Equivalent | |
| K033505 | RENACLEAN SH DIALYZER CLEANING SYSTEM | LIF | Substantially Equivalent | |
| K014016 | ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER | DWC | Substantially Equivalent | |
| K993042 | MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT | MED | Substantially Equivalent | |
| K991137 | ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER | DTR | Substantially Equivalent | |
| K000028 | RENAFLO II HF 2000 HEMOFILTER | KDI | Substantially Equivalent | |
| K991851 | RENACLEAR DIALYZER CLEANING SYSTEM | LIF | Substantially Equivalent | |
| K983126 | FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS | FIP | Substantially Equivalent | |
| K983085 | HEMOCOR HPH 700 HEMOCONCENTRATOR | KDI | Substantially Equivalent | |
| K980859 | HEMOCOR HPH MINI HEMOCONCENTRATOR | KDI | Substantially Equivalent | |
| K960513 | PERACT 20 LIQUID STERILANT | MED | Substantially Equivalent | |
| K972017 | BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR) | DTN | Substantially Equivalent | |
| K964967 | BIOCOR 200 HIGH PERFORMANCEOXYGENATOR | DTZ | Substantially Equivalent | |
| K962707 | MINNTECH MINNIFILTER PLUS HEMOFILTER AND TUBING SET | KDI | Substantially Equivalent | |
| K953821 | BIOCOR 200 HARDSHELL VENOUS RESERVIOR | DTN | Substantially Equivalent | |
| K954349 | FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS | FIP | Substantially Equivalent | |
| K941439 | RENALIN COLD STERILANT | LRJ | Substantially Equivalent | |
| K945136 | RENAGUARD DIALYSATE FILTER | FIP | Substantially Equivalent | |
| K923727 | PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000 | KDI | Substantially Equivalent | |
| K934292 | WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K914145 | DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES | FEB | Substantially Equivalent | |
| K923312 | HIGH PERMEABILITY DIALYER | KDI | Substantially Equivalent | |
| K923139 | HEMOCOR HP HEMOCONCENTRATOR SERIES | KDI | Substantially Equivalent | |
| K931935 | ENDPOINT 500 PERACETIC ACID TEST INDICATORS | JOJ | Substantially Equivalent | |
| K913483 | MINNILERT(R) PRESSURE MONITOR | KOC | Substantially Equivalent | |
| K910236 | RENAFLO HDF 1350 HEMODIAFILTER | KDI | Substantially Equivalent | |
| K904992 | MINNILERT AIR DETECTOR | FJF | Substantially Equivalent | |
| K904210 | RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330 | LIF | Substantially Equivalent | |
| K894970 | WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K882564 | RENALIN COLD STERILANT | LRJ | Substantially Equivalent | |
| K872456 | HEMOCOR PLUS HEMOCONCENTRATOR | KDI | Substantially Equivalent | |
| K872107 | WILLIAM HARVEY HF5000 MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K862402 | OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES | NVE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3018811167 | 3018811167 | MEDIVATORS INC | 14585 Northdale Blvd, Rogers, MN 55374 US | 2026 | |
| 1651395 | 3003012447 | Medivators Inc | 3150 Pollok Drive, Conroe, TX 77303 US | 2026 | and 8 more, listed in full below |
| 2150060 | 2150060 | Medivators Inc | 14605 28th Avenue North, MINNEAPOLIS, MN 55447 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- MNLAccessories, Cleaning Brushes, For Endoscope
- FEBAccessories, Cleaning, For Endoscope
- KDQBottle, Collection, Vacuum
- KTIBronchoscope Accessory
- FCYBulb, Inflation, For Endoscope
- FLGCleaner, Ultrasonic, Medical Instrument
- FDFColonoscope And Accessories, Flexible/Rigid
- DWCController, Temperature, Cardiopulmonary Bypass
- FAJCystoscope And Accessories, Flexible/Rigid
- FJFDetector, Air Bubble
- LIFDialyzer Reprocessing System
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- LRJDisinfectant, Medical Devices
- NIHDisinfectant, Subsystem, Water Purification
- KKXDrape, Surgical, Antimicrobial
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- ODCEndoscope Channel Accessory
- NWUEndoscope Introducer Kit
- PUPEndoscope Maintenance System
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- MNKEndoscopic Bite Block
- OCXEndoscopic Irrigation/Suction System
- FYAGown, Surgical
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- JOJIndicator, Physical/Chemical Sterilization Process
- FCXInsufflator, Automatic Carbon-Dioxide For Endoscope
- FTALight, Surgical, Accessories
- OEANon-Surgical Gown
- DTZOxygenator, Cardiopulmonary Bypass
- FEQPump, Air, Non-Manual, For Endoscope
- DTNReservoir, Blood, Cardiopulmonary Bypass
- MEDSterilant, Medical Devices
- MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant
- FIPSubsystem, Water Purification
- FKPSystem, Dialysate Delivery, Single Patient
- NKCTubing/Tubing With Filter, Insufflation, Laparoscopic
- NVEWasher, Cleaner, Automated, Endoscope
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1859-2021 | Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine. | The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation. | Class II | Terminated | |
| Z-1778-2020 | Medivators Endo carry-on Procedure Kit REF CPK-100222-0002 - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures. | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. | Class II | Terminated | |
| Z-1777-2020 | Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures. | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. | Class II | Terminated | |
| Z-1776-2020 | Medivators EndoGator REF 100650. Kit for Olympus 140/160/180/190 Series GI Endoscopes forCO2 Connection with Olympus OFP or Boston Scientific Endostat II Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures. | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. | Class II | Terminated | |
| Z-1775-2020 | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXT, packaged as Contents 1, 10, 50, and found in BMP-C145CO2EXT. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures. | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. | Class II | Terminated | |
| Z-1774-2020 | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2EXTU, packaged as Contents 1, 10, 50. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes With Extended CO2 Input. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures. | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. | Class II | Terminated | |
| Z-1773-2020 | Medivators Endo Smartcap Endoscope Tubing. REF100145CO2, packaged as Contents 1, 10, 50 and found in BMP-C145CO2. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures. | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. | Class II | Terminated | |
| Z-1772-2020 | Medivators Endo Smartcap Endoscope Tubing. REF100145. Packaged as Contents 1, 10, 50, and found in BMP-C145. Tubing for Olympus 140/240, 160/260, 180/280, 190/290 Series Endoscopes. Sterile EO - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures. | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve. | Class II | Terminated | |
| Z-2761-2015 | Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. | Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification. | Class II | Terminated | |
| Z-2213-2010 | DSD Application Guide (MG04-0001 revision M) for the Pentax Universal Video Scope Hookup (DSD-110-HU0109) only when used with the DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U endoscope. | The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope reprocessor or Medivators Scope Buddy Endoscope Flushing Aid. This may result in inadequate disinfection during reprocessing, and subsequent infection risk to the patient. The recall was due to the misprinte | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain