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

Bentley Laboratories, Inc. — Predicate Candidate Screening

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

42 daysmedian FDA review time

129 days90th percentile

55clearances measured

K-number	Device	Applicant	Decided	Review days
K931967	HE-30 GOLD	Bentley Laboratories, Inc.	1993-07-13	83
K913956	BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30	Bentley Laboratories, Inc.	1992-01-17	134
K913692	VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)	Bentley Laboratories, Inc.	1991-11-15	88
K903641	QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q	Bentley Laboratories, Inc.	1990-11-09	87
K894826	UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLF	Bentley Laboratories, Inc.	1990-02-28	212
K874841	INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER	Bentley Laboratories, Inc.	1988-02-02	70
K874867	CATR(TM)-H CARDIOTOMY HOLDER	Bentley Laboratories, Inc.	1988-02-02	67
K874618	BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER	Bentley Laboratories, Inc.	1988-01-19	71
K823359	OXYGEN CONSUMPTION MONITOR #OCM-0100	Bentley Laboratories, Inc.	1983-01-05	61
K823273	BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.	Bentley Laboratories, Inc.	1983-01-05	64
K823272	VENOUS RESERVOIR BAG #BMR-1400	Bentley Laboratories, Inc.	1982-12-30	58
K823456	OXYGENATORS #BOS-10, 105, 5S	Bentley Laboratories, Inc.	1982-12-30	42
K822803	BLOOD OXYGENATORS #BOS-105S BOS-5S W/	Bentley Laboratories, Inc.	1982-11-01	45
K821416	DISPOSABLE BLOOD PRESSURE TRANSDUCER	Bentley Laboratories, Inc.	1982-07-02	51
K820044	ARTERIAL BLOOD FILTER, #AF-1025	Bentley Laboratories, Inc.	1982-06-29	173
K820679	PEDIATRIC ARTERIAL BLOOD FILTER #AF-540	Bentley Laboratories, Inc.	1982-06-17	98
K820343	ARTERIAL BLOOD FILTER MODEL #AF-1040	Bentley Laboratories, Inc.	1982-06-17	129
K821495	DISPOSABLE BLOOD LINE CONNECTORS	Bentley Laboratories, Inc.	1982-05-27	8
K820243	CONTINUOUS BLOOD PROCESSOR CBP-6000 &	Bentley Laboratories, Inc.	1982-03-25	55
K820342	PHYSIOLOGICAL PRESSURE TRANSDUCER #900	Bentley Laboratories, Inc.	1982-03-04	24
K820045	CARDIOVASCULAR DEVICES	Bentley Laboratories, Inc.	1982-01-29	22
K820046	ANESTHESIOLOGY DEVICES	Bentley Laboratories, Inc.	1982-01-29	22
K813053	DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM	Bentley Laboratories, Inc.	1981-11-16	18
K812224	PLEURAL DRAINAGE SYSTEM #PDS-4300	Bentley Laboratories, Inc.	1981-09-09	30
K812173	FLUSHFLO II	Bentley Laboratories, Inc.	1981-08-18	15
K812009	CARDIOTOMY RESERVOIR W/FILTER#BCR-3500	Bentley Laboratories, Inc.	1981-07-28	11
K812008	CORDIOTOMY RESERVOIR	Bentley Laboratories, Inc.	1981-07-28	11
K811368	CARDIOPLEGIA COOLING & ADMIN. SETS	Bentley Laboratories, Inc.	1981-06-09	26
K811348	CARDIOPULMONARY BYPASS ACCESSORY EQUIP.	Bentley Laboratories, Inc.	1981-05-29	16
K810114	VASCULAR ACCESS SYSTEM	Bentley Laboratories, Inc.	1981-03-26	101
K802720	SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S	Bentley Laboratories, Inc.	1980-12-16	46
K802847	OXYGEN SATURATION METER MODEL NO. SM-1	Bentley Laboratories, Inc.	1980-12-16	34
K802719	SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S	Bentley Laboratories, Inc.	1980-12-16	46
K802848	CARDIOPLEGIA COOLING SYST. CCAS-2	Bentley Laboratories, Inc.	1980-12-11	29
K802378	QUICK PRIME LINES, #'S BPL-12, BPL-48 &	Bentley Laboratories, Inc.	1980-10-10	10
K802244	VESSEL RETRACTOR, #600732	Bentley Laboratories, Inc.	1980-10-03	17
K801640	SORIN PULSE GENERATOR, MODEL #LIT-214	Bentley Laboratories, Inc.	1980-10-03	78
K802133	BENTLEY THEROMODILUTION CATHETER #BTD-7F	Bentley Laboratories, Inc.	1980-09-26	22
K801147	PEDIATRIC ARTERIAL BLOOD FILTER #AF-5	Bentley Laboratories, Inc.	1980-06-04	22
K801240	BUILT-IN TEMPERATURE MONITORING	Bentley Laboratories, Inc.	1980-06-04	8
K792526	PULSE GENERATOR, MODEL NO. LIT 222	Bentley Laboratories, Inc.	1980-02-05	60
K792565	SORIN PULSE GENERATOR MODEL # LIT 214 H	Bentley Laboratories, Inc.	1980-02-05	60
K800135	CARDIOPLEGIA ADMINISTRATION SYSTEM CAS	Bentley Laboratories, Inc.	1980-02-01	11
K792450	ARTERIAL BLOOD FILTER, MODEL AF-10	Bentley Laboratories, Inc.	1979-12-19	16
K790308	DISPOSABLE DIALYZERS, SD-ID, SD-2D	Bentley Laboratories, Inc.	1979-05-01	77
K790635	Q220F CARDITOMY RESERVOIR/MODIFIED	Bentley Laboratories, Inc.	1979-04-18	16
K790361	RECIRCULATION FILTER MODEL RF-10	Bentley Laboratories, Inc.	1979-03-28	34
K780897	GENERATOR, PULSE, SORIN MODEL DL-1	Bentley Laboratories, Inc.	1978-12-06	188
K781842	OXYGENATOR, BLOOD BOS-10	Bentley Laboratories, Inc.	1978-11-08	12
K780078	OXYGENATOR, BUBBLE TYPE	Bentley Laboratories, Inc.	1978-09-14	240

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