BWC · Needle, Emergency Airway
Anesthesiology · 21 CFR 868.5090 · Class 2
Overview
| Product Code | BWC |
|---|---|
| Device Name | Needle, Emergency Airway |
| Regulation | 21 CFR 868.5090 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
| Life-Sustaining | Yes |
Identification
An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (14 of 14)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K200190 | ScalpelCric | VBM Medizintechnik GmbH | Oct 30, 2020 | SESE |
| K160200 | Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set | Cook Incorporated | Feb 17, 2017 | SESE |
| K153761 | Emergency Transtracheal Airway Catheter | Cook Incorporated | Sep 22, 2016 | SESE |
| K130405 | RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET | Teleflex Medical | Nov 6, 2013 | SESE |
| K050166 | PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT | Smiths Medical | May 26, 2005 | SESE |
| K013252 | PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET | Cook, Inc. | Feb 21, 2002 | SESE |
| K013241 | ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET | Cook, Inc. | Feb 21, 2002 | SESE |
| K013916 | MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET | Cook, Inc. | Dec 20, 2001 | SESE |
| K010016 | MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER | Cook, Inc. | Oct 9, 2001 | SESE |
| K962312 | KEY CHAIN EMERGENCY AIRWAY | Ffrench Pocket Emergency Airway, Inc. | Jun 17, 1997 | SESE |
| K952401 | ABELSON CRICOTHYROTOMY CANNULA | Gilbert Surgical Instruments, Inc. | Jul 11, 1995 | SESE |
| K853345 | 31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE | 31st. Centruy Medical Corp. | Oct 1, 1985 | SESE |
| K790650 | WEISS EMERGENCY AIRWAY SYSTEM | Intl. Medical Devices , Ltd. | Jun 27, 1979 | SESE |
| K771587 | INSTANT AIR | Hyde, Vernon E., D.D.S. | Sep 2, 1977 | SESE |
Top Applicants
- Cook, Inc. — 4 clearances
- Cook Incorporated — 2 clearances
- 31st. Centruy Medical Corp. — 1 clearance
- Ffrench Pocket Emergency Airway, Inc. — 1 clearance
- Gilbert Surgical Instruments, Inc. — 1 clearance
