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Single Use Manual Resuscitator

by Lifeguard Medical Products, Inc. 510(k)

Active United States

510(k) K881087

Overview

The Single Use Manual Resuscitator is a manual emergency ventilator designed for cardiopulmonary resuscitation (CPR) and artificial ventilation. Classified as a Ventilator, Emergency, Manual (Resuscitator) under FDA nomenclature, it provides positive-pressure ventilation to patients in need of immediate respiratory support during medical emergencies.

Intended for single-use applications, these devices are supplied sterile and are regulated under 21 CFR 868.5915. They are classified as Class II medical devices and have received FDA 510(k) clearance (K881087) with a decision of Substantially Equivalent. Multiple model references are listed, ensuring compatibility with various clinical settings. The devices are not reusable and must be discarded after one use to maintain sterility and safety.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881087 Date14 Apr 1988ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Lifeguard Single Use Manual Resuscitators
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

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