Atlas FDA

BWC

14 FDA 510(k) clearances · Product code

146 daysmedian time to decision
365 days90th percentile
14clearances measured

FDA profile

Official device name
Needle, Emergency Airway
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5090
Medical specialty
Anesthesiology
Flags
Life-sustaining · Third-party review eligible
Adverse events (MAUDE)
1998: 1 · 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
ScalpelCric (K200190)VBM Medizintechnik GmbH2020-10-30
Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set (K160200)Cook Incorporated2017-02-17
Emergency Transtracheal Airway Catheter (K153761)Cook Incorporated2016-09-22
RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET (K130405)Teleflex Medical2013-11-06
PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT (K050166)Smiths Medical2005-05-26
ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET (K013241)Cook, Inc.2002-02-21
PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET (K013252)Cook, Inc.2002-02-21
MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET (K013916)Cook, Inc.2001-12-20
MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER (K010016)Cook, Inc.2001-10-09
KEY CHAIN EMERGENCY AIRWAY (K962312)Ffrench Pocket Emergency Airway, Inc.1997-06-17
ABELSON CRICOTHYROTOMY CANNULA (K952401)Gilbert Surgical Instruments, Inc.1995-07-11
31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE (K853345)31st. Centruy Medical Corp.1985-10-01
WEISS EMERGENCY AIRWAY SYSTEM (K790650)Intl. Medical Devices , Ltd.1979-06-27
INSTANT AIR (K771587)Hyde, Vernon E., D.D.S.1977-09-02

Track BWC automatically

Every clearance here is in the API, with alerts when new ones post.