Product Code: BWC FDA class 2 21 CFR 868.5090

Needle, Emergency Airway

Anesthesiology

The Needle, Emergency Airway is a large-bore needle or cannula inserted percutaneously through the cricothyroid membrane or trachea to provide emergency oxygenation when conventional airway management has failed. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BWC, regulated under 21 CFR 868.5090 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting and is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: BWC
Device Class: FDA class 2
Regulation Number: 868.5090
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 14 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K200190	ScalpelCric	Oct 30, 2020	Substantially Equivalent	VBM Medizintechnik GmbH
K160200	Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set	Feb 17, 2017	Substantially Equivalent	Cook Incorporated
K153761	Emergency Transtracheal Airway Catheter	Sep 22, 2016	Substantially Equivalent	Cook Incorporated
K130405	RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET	Nov 06, 2013	Substantially Equivalent	Teleflex Medical
K050166	PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT	May 26, 2005	Substantially Equivalent	Smiths Medical
K013252	PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET	Feb 21, 2002	Substantially Equivalent	Cook, Inc.
K013241	ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET	Feb 21, 2002	Substantially Equivalent	Cook, Inc.
K013916	MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET	Dec 20, 2001	Substantially Equivalent	Cook, Inc.
K010016	MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER	Oct 09, 2001	Substantially Equivalent	Cook, Inc.
K962312	KEY CHAIN EMERGENCY AIRWAY	Jun 17, 1997	Substantially Equivalent	Ffrench Pocket Emergency Airway, Inc.
K952401	ABELSON CRICOTHYROTOMY CANNULA	Jul 11, 1995	Substantially Equivalent	Gilbert Surgical Instruments, Inc.
K853345	31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE	Oct 01, 1985	Substantially Equivalent	31st. Centruy Medical Corp.
K790650	WEISS EMERGENCY AIRWAY SYSTEM	Jun 27, 1979	Substantially Equivalent	Intl. Medical Devices , Ltd.
K771587	INSTANT AIR	Sep 02, 1977	Substantially Equivalent	Hyde, Vernon E., D.D.S.