Bentley Laboratories, Inc.
Mchenry, IL, US
Bentley Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 55 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 55
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 55FDA records hold 55 510(k) clearances for Bentley Laboratories, Inc. between 1976 and 1993. The busiest year on record is 1980, with 13. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 2 |
| 1978 | 4 |
| 1979 | 4 |
| 1980 | 13 |
| 1981 | 8 |
| 1982 | 12 |
| 1983 | 2 |
| 1988 | 3 |
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K931967 | HE-30 GOLD | DTR | Substantially Equivalent | |
| K913956 | BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 | DTN | Substantially Equivalent | |
| K913692 | VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) | DTN | Substantially Equivalent | |
| K903641 | QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q | KDI | Substantially Equivalent | |
| K894826 | UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF | DTZ | Substantially Equivalent | |
| K874867 | CATR(TM)-H CARDIOTOMY HOLDER | KPI | Substantially Equivalent | |
| K874841 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | DTZ | Substantially Equivalent | |
| K874618 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER | DQR | Substantially Equivalent | |
| K823359 | OXYGEN CONSUMPTION MONITOR #OCM-0100 | DRY | Substantially Equivalent | |
| K823273 | BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. | DTZ | Substantially Equivalent | |
| K823456 | OXYGENATORS #BOS-10, 105, 5S | DTZ | Substantially Equivalent | |
| K823272 | VENOUS RESERVOIR BAG #BMR-1400 | DTN | Substantially Equivalent | |
| K822803 | BLOOD OXYGENATORS #BOS-105S BOS-5S W/ | DTZ | Substantially Equivalent | |
| K821416 | DISPOSABLE BLOOD PRESSURE TRANSDUCER | DRS | Substantially Equivalent | |
| K820044 | ARTERIAL BLOOD FILTER, #AF-1025 | DTM | Substantially Equivalent | |
| K820679 | PEDIATRIC ARTERIAL BLOOD FILTER #AF-540 | DTM | Substantially Equivalent | |
| K820343 | ARTERIAL BLOOD FILTER MODEL #AF-1040 | DTM | Substantially Equivalent | |
| K821495 | DISPOSABLE BLOOD LINE CONNECTORS | KOC | Substantially Equivalent | |
| K820243 | CONTINUOUS BLOOD PROCESSOR CBP-6000 & | KDI | Substantially Equivalent | |
| K820342 | PHYSIOLOGICAL PRESSURE TRANSDUCER #900 | DRS | Substantially Equivalent | |
| K820046 | ANESTHESIOLOGY DEVICES | DRS | Substantially Equivalent | |
| K820045 | CARDIOVASCULAR DEVICES | DTM | Substantially Equivalent | |
| K813053 | DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM | DRS | Substantially Equivalent | |
| K812224 | PLEURAL DRAINAGE SYSTEM #PDS-4300 | KDQ | Substantially Equivalent | |
| K812173 | FLUSHFLO II | KRA | Substantially Equivalent | |
| K812009 | CARDIOTOMY RESERVOIR W/FILTER#BCR-3500 | DTN | Substantially Equivalent | |
| K812008 | CORDIOTOMY RESERVOIR | DTN | Substantially Equivalent | |
| K811368 | CARDIOPLEGIA COOLING & ADMIN. SETS | KRI | Substantially Equivalent | |
| K811348 | CARDIOPULMONARY BYPASS ACCESSORY EQUIP. | KRI | Substantially Equivalent | |
| K810114 | VASCULAR ACCESS SYSTEM | FIQ | Substantially Equivalent | |
| K802847 | OXYGEN SATURATION METER MODEL NO. SM-1 | Substantially Equivalent | ||
| K802720 | SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S | DTZ | Substantially Equivalent | |
| K802719 | SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S | DTZ | Substantially Equivalent | |
| K802848 | CARDIOPLEGIA COOLING SYST. CCAS-2 | DTR | Substantially Equivalent | |
| K802378 | QUICK PRIME LINES, #'S BPL-12, BPL-48 & | DWF | Substantially Equivalent | |
| K802244 | VESSEL RETRACTOR, #600732 | DXC | Substantially Equivalent | |
| K801640 | SORIN PULSE GENERATOR, MODEL #LIT-214 | DXY | Substantially Equivalent | |
| K802133 | BENTLEY THEROMODILUTION CATHETER #BTD-7F | KRB | Substantially Equivalent | |
| K801240 | BUILT-IN TEMPERATURE MONITORING | DTZ | Substantially Equivalent | |
| K801147 | PEDIATRIC ARTERIAL BLOOD FILTER #AF-5 | DTM | Substantially Equivalent | |
| K792565 | SORIN PULSE GENERATOR MODEL # LIT 214 H | DXY | Substantially Equivalent | |
| K792526 | PULSE GENERATOR, MODEL NO. LIT 222 | DXY | Substantially Equivalent | |
| K800135 | CARDIOPLEGIA ADMINISTRATION SYSTEM CAS | KRJ | Substantially Equivalent | |
| K792450 | ARTERIAL BLOOD FILTER, MODEL AF-10 | DTM | Substantially Equivalent | |
| K790308 | DISPOSABLE DIALYZERS, SD-ID, SD-2D | FJI | Substantially Equivalent | |
| K790635 | Q220F CARDITOMY RESERVOIR/MODIFIED | DTN | Substantially Equivalent | |
| K790361 | RECIRCULATION FILTER MODEL RF-10 | KRJ | Substantially Equivalent | |
| K780897 | GENERATOR, PULSE, SORIN MODEL DL-1 | DXY | Substantially Equivalent | |
| K781842 | OXYGENATOR, BLOOD BOS-10 | DTZ | Substantially Equivalent | |
| K780078 | OXYGENATOR, BUBBLE TYPE | DTZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- KRIAccessory Equipment, Cardiopulmonary Bypass
- EJTAlloy, Gold-Based Noble Metal
- KDQBottle, Collection, Vacuum
- FIQCannula, A-V Shunt
- DQRCannula, Catheter
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- KRACatheter, Continuous Flush
- DXCClamp, Vascular
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- FHSDialyzer, Single Coil
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- KRJFilter, Prebypass, Cardiopulmonary Bypass
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DXYImplantable Pacemaker Pulse-Generator
- CAKMicrofilter, Blood Transfusion
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- DTZOxygenator, Cardiopulmonary Bypass
- KRBProbe, Thermodilution
- DTNReservoir, Blood, Cardiopulmonary Bypass
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- DRSTransducer, Blood-Pressure, Extravascular
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain