Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

American Bentley — Predicate Candidate Screening

59 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

75 daysmedian FDA review time

186 days90th percentile

59clearances measured

K-number	Device	Applicant	Decided	Review days
K872896	UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100	American Bentley	1988-02-12	204
K873923	INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER	American Bentley	1987-11-06	42
K870804	CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100	American Bentley	1987-09-01	186
K872167	CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500	American Bentley	1987-09-01	85
K872133	OXYGENATOR MODEL NO. BENTLEY 5 PLUS	American Bentley	1987-08-24	83
K870911	INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY	American Bentley	1987-05-29	84
K870269	ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100	American Bentley	1987-03-09	45
K863249	OXYGENATOR MODEL NO. BENTLEY-10 PLUS	American Bentley	1986-10-20	59
K861641	HEPARIN-COATED EXTRACORPOREAL CIRCUITS	American Bentley	1986-09-29	152
K862549	ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE	American Bentley	1986-07-15	12
K860673	OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B	American Bentley	1986-06-26	122
K860672	ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL	American Bentley	1986-03-03	7
K860106	OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100	American Bentley	1986-02-26	44
K854113	CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH	American Bentley	1986-01-08	92
K854045	MEMBRANE OXYGENATING SYS ADULT BMOS-7 & BMOS-3 PED	American Bentley	1985-12-16	75
K853950	ARTERIAL/VENOUS SAMPLE LINE BOS-CMSL	American Bentley	1985-12-11	77
K853786	OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100	American Bentley	1985-10-16	36
K852382	CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR	American Bentley	1985-09-25	112
K852124	HEMATOCRIT-SATURATION MONITOR HSM-100	American Bentley	1985-09-16	124
K841811	BENTLEY-TRANTEC DISPOS. DOMES D-260-	American Bentley	1985-09-09	496
K852683	ELECTROSURGICAL LATERAL RELEASE PROBE MOD ALR-100	American Bentley	1985-08-12	48
K851376	VENOUS RESERVOIR BAG BMR-1600	American Bentley	1985-06-25	78
K851401	VENUOS RESERVOIR BAG BMR-1900	American Bentley	1985-06-25	77
K833047	DOSIMETRIC RELEASE OF RAD. TUBING PAC	American Bentley	1985-06-11	644
K850925	BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER	American Bentley	1985-05-21	77
K851035	AMERICAN BENTLEY OXYGENATOR MAX-2	American Bentley	1985-05-16	64
K850630	BLOOD OXYGENATOR MODEL NO. MAX-5	American Bentley	1985-03-27	36
K844901	AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH	American Bentley	1985-03-07	80
K844366	CARDIOTOMY RESERVOIR BCR-2000	American Bentley	1985-01-14	62
K844367	CARDIOTOMY RESERVOIR W/FILTER BCR-2500	American Bentley	1985-01-14	62
K842813	HEPARIN COATED ARTERIAL BLOOD FILTERS	American Bentley	1985-01-08	174
K842373	VENOUS RESERVOIR-BMR-1500-HARD SHELL	American Bentley	1984-12-27	195
K843504	AMER. BENTLEY HEMOFILTER HOLDER HFH-1	American Bentley	1984-10-18	42
K841585	AMER. BENTLEY CONTINU-BLOOD PROCESSOR-	American Bentley	1984-10-18	184
K842620	CARDIOTOMY RESERVOIR W/FILTER BCR-3500	American Bentley	1984-08-27	53
K841476	TUBULAR HOLLOW FIBER MEMBRANE	American Bentley	1984-08-03	116
K841938	CARDIOPLEGIA RESERVOIR CAS-2000	American Bentley	1984-08-03	84
K840023	TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC	American Bentley	1984-06-22	169
K841812	HOLDER FOR BOS-10, 10S 5S	American Bentley	1984-06-11	41
K841031	OXYHI CRYSTALLOID CARDIOPLEGIA SOLUT	American Bentley	1984-05-23	72
K840612	PEDIATRIC ARTERIAL BLOOD FILTER	American Bentley	1984-04-17	64
K841032	HOLDER FOR MODELS AF-10,1025,1040,5	American Bentley	1984-04-17	36
K840256	CARDIOPLEGIA HEAT EXCHANGER HOLDER	American Bentley	1984-02-17	25
K840045	CARDIOPLEGIA HEAT EXCHANGER HE-100	American Bentley	1984-02-13	38
K833792	TRANTECSILICONE QUARTZ DISP. TRANSD	American Bentley	1984-02-10	102
K834373	CARDIOTOMY RESERVORS BCR-3000/3500-Q-120	American Bentley	1984-02-04	54
K833670	BOS-CM40,50 HOLDER & RESERVOIR BAG	American Bentley	1984-01-03	77
K831849	PLEURAL DRAINAGE SYS #PDS-100-4	American Bentley	1983-12-29	204
K832802	USE OF TWEEN 80 AS A WETTING AGENT ON	American Bentley	1983-12-29	133
K833518	BLOOD OXYGENATOR HEAT EXHANGER COATING	American Bentley	1983-12-29	79

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda