American Bentley
Mchenry, IL, US
American Bentley appears in FDA device records in Mchenry, IL. FDA records list 59 510(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
- 59
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 59FDA records hold 59 510(k) clearances for American Bentley between 1983 and 1988. The busiest year on record is 1985, with 17. The most recent is 1988, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 12 |
| 1984 | 16 |
| 1985 | 17 |
| 1986 | 7 |
| 1987 | 6 |
| 1988 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K872896 | UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 | CCE | Substantially Equivalent | |
| K873923 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER | DTZ | Substantially Equivalent | |
| K872167 | CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500 | DTP | Substantially Equivalent | |
| K870804 | CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100 | DTR | Substantially Equivalent | |
| K872133 | OXYGENATOR MODEL NO. BENTLEY 5 PLUS | DTZ | Substantially Equivalent | |
| K870911 | INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY | CCC | Substantially Equivalent | |
| K870269 | ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 | GEI | Substantially Equivalent | |
| K863249 | OXYGENATOR MODEL NO. BENTLEY-10 PLUS | DTZ | Substantially Equivalent | |
| K861641 | HEPARIN-COATED EXTRACORPOREAL CIRCUITS | DTZ | Substantially Equivalent | |
| K862549 | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE | KRI | Substantially Equivalent | |
| K860673 | OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B | DTZ | Substantially Equivalent | |
| K860672 | ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL | KRI | Substantially Equivalent | |
| K860106 | OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100 | CCE | Substantially Equivalent | |
| K854113 | CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH | KRI | Substantially Equivalent | |
| K854045 | MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED | DTZ | Substantially Equivalent | |
| K853950 | ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL | DTL | Substantially Equivalent | |
| K853786 | OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100 | CCE | Substantially Equivalent | |
| K852382 | CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR | DTN | Substantially Equivalent | |
| K852124 | HEMATOCRIT-SATURATION MONITOR HSM-100 | DRY | Substantially Equivalent | |
| K841811 | BENTLEY-TRANTEC DISPOS. DOMES D-260- | DRS | Substantially Equivalent | |
| K852683 | ELECTROSURGICAL LATERAL RELEASE PROBE MOD ALR-100 | GEI | Substantially Equivalent | |
| K851401 | VENUOS RESERVOIR BAG BMR-1900 | DTN | Substantially Equivalent | |
| K851376 | VENOUS RESERVOIR BAG BMR-1600 | DTN | Substantially Equivalent | |
| K833047 | DOSIMETRIC RELEASE OF RAD. TUBING PAC | DWF | Substantially Equivalent | |
| K850925 | BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER | DWF | Substantially Equivalent | |
| K851035 | AMERICAN BENTLEY OXYGENATOR MAX-2 | DTZ | Substantially Equivalent | |
| K850630 | BLOOD OXYGENATOR MODEL NO. MAX-5 | DTZ | Substantially Equivalent | |
| K844901 | AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH | DTZ | Substantially Equivalent | |
| K844367 | CARDIOTOMY RESERVOIR W/FILTER BCR-2500 | DTN | Substantially Equivalent | |
| K844366 | CARDIOTOMY RESERVOIR BCR-2000 | DTN | Substantially Equivalent | |
| K842813 | HEPARIN COATED ARTERIAL BLOOD FILTERS | DTM | Substantially Equivalent | |
| K842373 | VENOUS RESERVOIR-BMR-1500-HARD SHELL | DTP | Substantially Equivalent | |
| K843504 | AMER. BENTLEY HEMOFILTER HOLDER HFH-1 | FKI | Substantially Equivalent | |
| K841585 | AMER. BENTLEY CONTINU-BLOOD PROCESSOR- | KDI | Substantially Equivalent | |
| K842620 | CARDIOTOMY RESERVOIR W/FILTER BCR-3500 | DTN | Substantially Equivalent | |
| K841938 | CARDIOPLEGIA RESERVOIR CAS-2000 | DTN | Substantially Equivalent | |
| K841476 | TUBULAR HOLLOW FIBER MEMBRANE | DTZ | Substantially Equivalent | |
| K840023 | TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC | DRS | Substantially Equivalent | |
| K841812 | HOLDER FOR BOS-10, 10S 5S | KRI | Substantially Equivalent | |
| K841031 | OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT | DTN | Substantially Equivalent | |
| K841032 | HOLDER FOR MODELS AF-10,1025,1040,5 | KRI | Substantially Equivalent | |
| K840612 | PEDIATRIC ARTERIAL BLOOD FILTER | DTM | Substantially Equivalent | |
| K840256 | CARDIOPLEGIA HEAT EXCHANGER HOLDER | DTR | Substantially Equivalent | |
| K840045 | CARDIOPLEGIA HEAT EXCHANGER HE-100 | DTR | Substantially Equivalent | |
| K833792 | TRANTECSILICONE QUARTZ DISP. TRANSD | DRS | Substantially Equivalent | |
| K834373 | CARDIOTOMY RESERVORS BCR-3000/3500-Q-120 | DTN | Substantially Equivalent | |
| K833670 | BOS-CM40,50 HOLDER & RESERVOIR BAG | DTZ | Substantially Equivalent | |
| K833518 | BLOOD OXYGENATOR HEAT EXHANGER COATING | DTZ | Substantially Equivalent | |
| K832802 | USE OF TWEEN 80 AS A WETTING AGENT ON | DTN | Substantially Equivalent | |
| K831849 | PLEURAL DRAINAGE SYS #PDS-100-4 | CAC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KRIAccessory Equipment, Cardiopulmonary Bypass
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- CCCAnalyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
- CCEAnalyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- CACApparatus, Autotransfusion
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DTPDefoamer, Cardiopulmonary Bypass
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- DTZOxygenator, Cardiopulmonary Bypass
- DTNReservoir, Blood, Cardiopulmonary Bypass
- FKISet, Dialyzer Holder
- DRSTransducer, Blood-Pressure, Extravascular
- DXOTransducer, Pressure, Catheter Tip
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets American Bentley edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for American Bentley. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain