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

BWN — Predicate Candidate Screening

20 FDA 510(k) clearances under this product code; the 50 most recent screened below.

32 daysmedian FDA review time

209 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days
K942699	AIRFRAME SURGICAL DRAPE SUPPORT	Alpha Surgical, Inc.	1994-07-13	35
K935441	INFINITECH BREATH EZ	Infinitech, Inc.	1994-02-07	87
K925005	ISI SELF-SUPPORTING ARM	Instrumentation Specialties, Inc.	1993-04-29	209
K922288	HOLDER, PEDIATRIC POSITION	Yamashita and Hemsley Business Trust	1993-02-10	271
K910783	SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M	Smith & Nephew Equipment Group	1991-04-02	36
K902865	BAUMER SURGICAL TABLE	Sds Dental, Inc.	1990-09-10	73
K884558	IOP ADJUSTABLE STIRRUP	Mend Technologies, Inc.	1988-11-17	17
K875291	SPINAL SURGERY FRAME	T. Korossurgical Instruments Corp.	1988-01-22	23
K873272	ENDOSCOPY TABLE 1532 ENDOSTAR	Stierlen-Maquet AG	1987-09-08	22
K860177	ALLEN UNIVERSAL STIRRUP	Edgewater Medical Equipment Systems	1986-02-11	25
K852332	TABLE ACCESSORIES, OPERATING ROOM	Scholten Surgical Instruments, Inc.	1985-07-02	32
K843121	GUIDE TO THE KNEE	Dyonics, Inc.	1984-09-07	30
K832340	OPERATING ROOM TABLES HYDRAULIC	Kamiya Tsusan Kaisha, Ltd.	1983-08-12	31
K823772	AMSCO ORTHOGRAPHIC 2 TABLE	American Sterilizer Co.	1983-01-14	31
K820574	ARMBOARD FOR INTRAVENOUS ANES. IN DENTAL	David Simmonds Co., Inc.	1982-03-23	21
K812396	ARTHRO-PREP REST	Northwest Surgical Concepts, Inc.	1981-11-20	92
K812395	ARTHRO-PREP REST W/STAND	Northwest Surgical Concepts, Inc.	1981-11-20	92
K802271	THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC	The Anspach Effort, Inc.	1980-10-23	36
K792569	OPERATING TABLES & AMPLINOX 03	Ets Rene Marzet	1980-01-04	22
K791859	TECNOL STIRRUPS STRAP	Tecnol New Jersey Wound Care, Inc.	1979-10-04	16

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