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

Boehringer Laboratories — Predicate Candidate Screening

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

84 daysmedian FDA review time

328 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K234145	ViSiGi 3D Gastric Sizing Tube	Boehringer Laboratories	2024-01-26	28	0
K061788	BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM	Boehringer Laboratories	2006-07-11	15	5
K060277	BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM	Boehringer Laboratories	2006-03-03	29	0
K020538	BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYS	Boehringer Laboratories	2002-05-15	85	0
K014187	AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM	Boehringer Laboratories	2002-02-06	47	0
K013976	BOEHRINGER MRI SUCTION REGULATORY	Boehringer Laboratories	2002-01-08	36	0
K955010	AUTOVAC BP SYSTE, 2000 SERIES	Boehringer Laboratories	1996-06-20	232	0
K945775	BOEHRINGER AUTOVAC(R) 7900 SERIES	Boehringer Laboratories	1995-10-19	328	0
K932093	AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S	Boehringer Laboratories	1994-07-06	432	1
K933232	BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED	Boehringer Laboratories	1994-03-28	265	0
K930615	AUTOVAC CLOSED WOUND SUCTION SYSTEM	Boehringer Laboratories	1994-02-22	382	0
K934390	OSCILLATING BONE SAW BLADE, 6200 SERIES	Boehringer Laboratories	1994-01-26	139	0
K924894	AUTOVAC 7900 SERIES	Boehringer Laboratories	1993-02-05	130	0
K924953	FLUID COOLED BONE SAW BLADE, 6000 SERIES	Boehringer Laboratories	1993-01-21	113	0
K904164	AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED	Boehringer Laboratories	1991-09-06	360	0
K904888	AUTOWAND(TM) 7XXX SERIES, MODIFICATION	Boehringer Laboratories	1991-01-16	82	0
K902059	AUTOWAND(TM) 7XXX SERIES	Boehringer Laboratories	1990-07-24	78	0
K901138	AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES	Boehringer Laboratories	1990-06-18	98	0
K895297	AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION	Boehringer Laboratories	1990-03-13	200	0
K884103	REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES	Boehringer Laboratories	1989-03-03	155	0
K881129	AUTO-VAC INTRAOPERATIVE AUTOTRANS. RESERVOIR #7904	Boehringer Laboratories	1988-06-14	90	0
K873521	BRONCHODILATOR TEE - 9056 SERIES	Boehringer Laboratories	1988-03-02	183	0
K862684	AUTO-VAC (TM) AUTOTRANSFUSION RESERV, MODEL 7900	Boehringer Laboratories	1986-10-17	94	0
K861025	T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES	Boehringer Laboratories	1986-04-28	41	0
K855074	FILTERED VACUUM SAFETY TRAP BOTTLE	Boehringer Laboratories	1986-03-13	84	0
K853155	BOEHRINGER LAB SUCTION INTERRUPTER	Boehringer Laboratories	1985-10-16	79	0
K853095	BOEHRINGER LABORATORIES SUCTION INTERMITTOR	Boehringer Laboratories	1985-08-23	31	3
K850200	SUCTION REGULATOR 7700 SERIES	Boehringer Laboratories	1985-03-04	45	0
K832868	RESUSCITATION VALVE	Boehringer Laboratories	1983-09-26	33	0
K822689	PORTABLE MONITORING & SCREENING SPIROM.	Boehringer Laboratories	1983-07-12	312	0
K800755	BOEHRINGER LABS AMBULATORY PEEP VALVE	Boehringer Laboratories	1980-05-08	34	0
K792155	CO 2 METER	Boehringer Laboratories	1979-11-27	34	0
K790248	NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD)	Boehringer Laboratories	1979-04-04	55	0
K782145	SPIROMETER, MINI POSITIVE	Boehringer Laboratories	1979-01-31	35	0
K771532	SPIROMETEO & LUNG EXERCISER, 4601	Boehringer Laboratories	1977-08-26	16	0
K770406	TECHNICON SMA & AAII SYSTEMS	Boehringer Laboratories	1977-06-02	91	0
K760971	POSITIVE DISPLACEMENT SPIROMETER	Boehringer Laboratories	1976-12-09	35	0
K760453	REGULATOR, PRESSURE, CUFF	Boehringer Laboratories	1976-09-13	28	0

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