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

Augustine Medical, Inc. — Predicate Candidate Screening

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

92 daysmedian FDA review time

211 days90th percentile

25clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K021473	BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM	Augustine Medical, Inc.	2002-07-09	62	0
K020077	MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 6	Augustine Medical, Inc.	2002-01-31	22	0
K001149	AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE M	Augustine Medical, Inc.	2000-09-06	149	1
K973741	BAIR HUGGER BLOOD/FLUID WARMER	Augustine Medical, Inc.	1998-04-30	211	3
K964673	BAIR HUGGER MODEL 630 CARDIAC BLANKET	Augustine Medical, Inc.	1997-06-26	217	0
K963293	AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX	Augustine Medical, Inc.	1997-03-28	219	0
K963672	MODEL 90022 ROLLING STAND	Augustine Medical, Inc.	1997-01-06	115	0
K960167	SYSTEM, THERMAL REGULATING 74-DWJ	Augustine Medical, Inc.	1996-06-17	153	0
K954446	AUGUSTINE INTUBATION GUIDE	Augustine Medical, Inc.	1995-12-29	95	0
K952864	BAIR HUGGER MODEL 655 BLANKET	Augustine Medical, Inc.	1995-09-12	82	0
K950416	BAIR HUGGER MODEL 600 UNIT, BLANKETS	Augustine Medical, Inc.	1995-08-29	210	0
K933726	MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM	Augustine Medical, Inc.	1994-01-28	179	0
K921165	BAIR HUGGER TORSO BLANKET - ARMS IN MODEL 540	Augustine Medical, Inc.	1992-08-06	148	0
K920432	BAIR HUGGER CUB BLANKET- SHORT MODEL 536	Augustine Medical, Inc.	1992-06-18	136	0
K915161	AUGUSTINE FIBEROPTIC LARYNGOSCOPE	Augustine Medical, Inc.	1992-05-29	197	0
K921166	AUGUSTINE GUIDE KIT	Augustine Medical, Inc.	1992-04-23	43	0
K920468	AUGUSTINE STYLET	Augustine Medical, Inc.	1992-04-23	87	0
K920265	BAIR HUGGER PATIENT WARMING SYSTEM	Augustine Medical, Inc.	1992-03-27	66	0
K913734	BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER	Augustine Medical, Inc.	1991-10-23	64	1
K914168	AUGUSTINE GUIDE KIT WITH GAUZE SPONGE	Augustine Medical, Inc.	1991-10-07	20	0
K912690	AUGUSTINE GUIDE(TM) KIT	Augustine Medical, Inc.	1991-09-04	78	0
K910659	AUGUSTINE STYLET	Augustine Medical, Inc.	1991-05-17	92	0
K903360	BAIR HUGGER(R) PATIENT WARMING SYSTEM-MODIFICATION	Augustine Medical, Inc.	1990-08-14	29	0
K882659	AUGUSTINE INTUBATION GUIDE(TM)	Augustine Medical, Inc.	1988-07-21	23	0
K873745	BAIR HUGGER(TM) - PATIENT WARMING SYSTEM	Augustine Medical, Inc.	1987-11-06	51	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