Company ยท US
Bentley Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1993. Name variants (Inc, Corp, punctuation) are merged.
55510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 10 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 6 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 6 |
| DRS | Transducer, Blood-Pressure, Extravascular | 4 |
| DXY | Implantable Pacemaker Pulse-Generator | 4 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 2 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 2 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 2 |
| KRA | Catheter, Continuous Flush | 2 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 2 |
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 2 |
| CAK | Microfilter, Blood Transfusion | 1 |
| DQR | Cannula, Catheter | 1 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| DXC | Clamp, Vascular | 1 |
| EJT | Alloy, Gold-Based Noble Metal | 1 |
| FHS | Dialyzer, Single Coil | 1 |
| FIQ | Cannula, A-V Shunt | 1 |
| KDQ | Bottle, Collection, Vacuum | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 13, 1993 | K931967 | HE-30 GOLD Bentley Laboratories, Inc. | DTR |
| Jan 17, 1992 | K913956 | BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30 Bentley Laboratories, Inc. | DTN |
| Nov 15, 1991 | K913692 | VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM) Bentley Laboratories, Inc. | DTN |
| Nov 9, 1990 | K903641 | QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q Bentley Laboratories, Inc. | KDI |
| Feb 28, 1990 | K894826 | UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF Bentley Laboratories, Inc. | DTZ |
| Feb 2, 1988 | K874867 | CATR(TM)-H CARDIOTOMY HOLDER Bentley Laboratories, Inc. | KPI |
| Feb 2, 1988 | K874841 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER Bentley Laboratories, Inc. | DTZ |
| Jan 19, 1988 | K874618 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER Bentley Laboratories, Inc. | DQR |
| Jan 5, 1983 | K823359 | OXYGEN CONSUMPTION MONITOR #OCM-0100 Bentley Laboratories, Inc. | DRY |
| Jan 5, 1983 | K823273 | BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN. Bentley Laboratories, Inc. | DTZ |
| Dec 30, 1982 | K823456 | OXYGENATORS #BOS-10, 105, 5S Bentley Laboratories, Inc. | DTZ |
| Dec 30, 1982 | K823272 | VENOUS RESERVOIR BAG #BMR-1400 Bentley Laboratories, Inc. | DTN |
| Nov 1, 1982 | K822803 | BLOOD OXYGENATORS #BOS-105S BOS-5S W/ Bentley Laboratories, Inc. | DTZ |
| Jul 2, 1982 | K821416 | DISPOSABLE BLOOD PRESSURE TRANSDUCER Bentley Laboratories, Inc. | DRS |
| Jun 29, 1982 | K820044 | ARTERIAL BLOOD FILTER, #AF-1025 Bentley Laboratories, Inc. | DTM |
| Jun 17, 1982 | K820679 | PEDIATRIC ARTERIAL BLOOD FILTER #AF-540 Bentley Laboratories, Inc. | DTM |
| Jun 17, 1982 | K820343 | ARTERIAL BLOOD FILTER MODEL #AF-1040 Bentley Laboratories, Inc. | DTM |
| May 27, 1982 | K821495 | DISPOSABLE BLOOD LINE CONNECTORS Bentley Laboratories, Inc. | KOC |
| Mar 25, 1982 | K820243 | CONTINUOUS BLOOD PROCESSOR CBP-6000 & Bentley Laboratories, Inc. | KDI |
| Mar 4, 1982 | K820342 | PHYSIOLOGICAL PRESSURE TRANSDUCER #900 Bentley Laboratories, Inc. | DRS |
| Jan 29, 1982 | K820046 | ANESTHESIOLOGY DEVICES Bentley Laboratories, Inc. | DRS |
| Jan 29, 1982 | K820045 | CARDIOVASCULAR DEVICES Bentley Laboratories, Inc. | DTM |
| Nov 16, 1981 | K813053 | DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM Bentley Laboratories, Inc. | DRS |
| Sep 9, 1981 | K812224 | PLEURAL DRAINAGE SYSTEM #PDS-4300 Bentley Laboratories, Inc. | KDQ |
| Aug 18, 1981 | K812173 | FLUSHFLO II Bentley Laboratories, Inc. | KRA |
| Jul 28, 1981 | K812009 | CARDIOTOMY RESERVOIR W/FILTER#BCR-3500 Bentley Laboratories, Inc. | DTN |
| Jul 28, 1981 | K812008 | CORDIOTOMY RESERVOIR Bentley Laboratories, Inc. | DTN |
| Jun 9, 1981 | K811368 | CARDIOPLEGIA COOLING & ADMIN. SETS Bentley Laboratories, Inc. | KRI |
| May 29, 1981 | K811348 | CARDIOPULMONARY BYPASS ACCESSORY EQUIP. Bentley Laboratories, Inc. | KRI |
| Mar 26, 1981 | K810114 | VASCULAR ACCESS SYSTEM Bentley Laboratories, Inc. | FIQ |
| Dec 16, 1980 | K802847 | OXYGEN SATURATION METER MODEL NO. SM-1 Bentley Laboratories, Inc. | |
| Dec 16, 1980 | K802720 | SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S Bentley Laboratories, Inc. | DTZ |
| Dec 16, 1980 | K802719 | SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S Bentley Laboratories, Inc. | DTZ |
| Dec 11, 1980 | K802848 | CARDIOPLEGIA COOLING SYST. CCAS-2 Bentley Laboratories, Inc. | DTR |
| Oct 10, 1980 | K802378 | QUICK PRIME LINES, #'S BPL-12, BPL-48 & Bentley Laboratories, Inc. | DWF |
| Oct 3, 1980 | K802244 | VESSEL RETRACTOR, #600732 Bentley Laboratories, Inc. | DXC |
| Oct 3, 1980 | K801640 | SORIN PULSE GENERATOR, MODEL #LIT-214 Bentley Laboratories, Inc. | DXY |
| Sep 26, 1980 | K802133 | BENTLEY THEROMODILUTION CATHETER #BTD-7F Bentley Laboratories, Inc. | KRB |
| Jun 4, 1980 | K801240 | BUILT-IN TEMPERATURE MONITORING Bentley Laboratories, Inc. | DTZ |
| Jun 4, 1980 | K801147 | PEDIATRIC ARTERIAL BLOOD FILTER #AF-5 Bentley Laboratories, Inc. | DTM |
| Feb 5, 1980 | K792565 | SORIN PULSE GENERATOR MODEL # LIT 214 H Bentley Laboratories, Inc. | DXY |
| Feb 5, 1980 | K792526 | PULSE GENERATOR, MODEL NO. LIT 222 Bentley Laboratories, Inc. | DXY |
| Feb 1, 1980 | K800135 | CARDIOPLEGIA ADMINISTRATION SYSTEM CAS Bentley Laboratories, Inc. | KRJ |
| Dec 19, 1979 | K792450 | ARTERIAL BLOOD FILTER, MODEL AF-10 Bentley Laboratories, Inc. | DTM |
| May 1, 1979 | K790308 | DISPOSABLE DIALYZERS, SD-ID, SD-2D Bentley Laboratories, Inc. | FJI |
| Apr 18, 1979 | K790635 | Q220F CARDITOMY RESERVOIR/MODIFIED Bentley Laboratories, Inc. | DTN |
| Mar 28, 1979 | K790361 | RECIRCULATION FILTER MODEL RF-10 Bentley Laboratories, Inc. | KRJ |
| Dec 6, 1978 | K780897 | GENERATOR, PULSE, SORIN MODEL DL-1 Bentley Laboratories, Inc. | DXY |
| Nov 8, 1978 | K781842 | OXYGENATOR, BLOOD BOS-10 Bentley Laboratories, Inc. | DTZ |
| Sep 14, 1978 | K780078 | OXYGENATOR, BUBBLE TYPE Bentley Laboratories, Inc. | DTZ |
Newest 50 of 55.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||