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

BWC — Predicate Candidate Screening

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

146 daysmedian FDA review time

365 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K200190	ScalpelCric	VBM Medizintechnik GmbH	2020-10-30	277	0
K160200	Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker	Cook Incorporated	2017-02-17	386	1
K153761	Emergency Transtracheal Airway Catheter	Cook Incorporated	2016-09-22	267	0
K130405	RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET	Teleflex Medical	2013-11-06	260	0
K050166	PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT	Smiths Medical	2005-05-26	120	0
K013241	ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET	Cook, Inc.	2002-02-21	146	0
K013252	PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET	Cook, Inc.	2002-02-21	146	0
K013916	MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET	Cook, Inc.	2001-12-20	23	0
K010016	MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER	Cook, Inc.	2001-10-09	280	1
K962312	KEY CHAIN EMERGENCY AIRWAY	Ffrench Pocket Emergency Airway, Inc.	1997-06-17	365	0
K952401	ABELSON CRICOTHYROTOMY CANNULA	Gilbert Surgical Instruments, Inc.	1995-07-11	50	0
K853345	31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE	31st. Centruy Medical Corp.	1985-10-01	50	0
K790650	WEISS EMERGENCY AIRWAY SYSTEM	Intl. Medical Devices , Ltd.	1979-06-27	85	0
K771587	INSTANT AIR	Hyde, Vernon E., D.D.S.	1977-09-02	15	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