Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5090](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5090) → BWC — Needle, Emergency Airway

# BWC · Needle, Emergency Airway

_Anesthesiology · 21 CFR 868.5090 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC

## Overview

- **Product Code:** BWC
- **Device Name:** Needle, Emergency Airway
- **Regulation:** [21 CFR 868.5090](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5090)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K200190.md) | ScalpelCric | VBM Medizintechnik GmbH | Oct 30, 2020 | SESE |
| [K160200](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K160200.md) | Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set | Cook Incorporated | Feb 17, 2017 | SESE |
| [K153761](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K153761.md) | Emergency Transtracheal Airway Catheter | Cook Incorporated | Sep 22, 2016 | SESE |
| [K130405](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K130405.md) | RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET | Teleflex Medical | Nov 6, 2013 | SESE |
| [K050166](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K050166.md) | PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT | Smiths Medical | May 26, 2005 | SESE |
| [K013252](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K013252.md) | PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET | Cook, Inc. | Feb 21, 2002 | SESE |
| [K013241](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K013241.md) | ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET | Cook, Inc. | Feb 21, 2002 | SESE |
| [K013916](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K013916.md) | MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET | Cook, Inc. | Dec 20, 2001 | SESE |
| [K010016](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K010016.md) | MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER | Cook, Inc. | Oct 9, 2001 | SESE |
| [K962312](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K962312.md) | KEY CHAIN EMERGENCY AIRWAY | Ffrench Pocket Emergency Airway, Inc. | Jun 17, 1997 | SESE |
| [K952401](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K952401.md) | ABELSON CRICOTHYROTOMY CANNULA | Gilbert Surgical Instruments, Inc. | Jul 11, 1995 | SESE |
| [K853345](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K853345.md) | 31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE | 31st. Centruy Medical Corp. | Oct 1, 1985 | SESE |
| [K790650](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K790650.md) | WEISS EMERGENCY AIRWAY SYSTEM | Intl. Medical Devices , Ltd. | Jun 27, 1979 | SESE |
| [K771587](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K771587.md) | 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

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC)

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