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Air-Shields Resuscitators

by Narco Air-Shields

510(k) K792118

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK792118 Date13 Nov 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
BTM
Device Class
Class II
Regulation
21 CFR Part 868.5915
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Air-Shields Resuscitators are manual emergency ventilators classified as Ventilator, Emergency, Manual (Resuscitator) under product code BTM. They are designed for emergency respiratory support and are substantially equivalent to predicate devices as determined by FDA 510(k) clearance.

The device is supplied by Narco Air-Shields and received FDA 510(k) clearance (K792118) on November 13, 1979, following a traditional review. It is a Class II device subject to special controls, with regulatory classification under 21 CFR 868.5915. No information on sterility, single-use or reusable status, MRI safety, sizes, storage, or clinical indications is provided in the data.

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