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Mouth to Mask Resuscitator

by Vital Signs, Inc. 510(k)

Active United States

510(k) K912625

Overview

A mouth to mask resuscitator is a manual emergency ventilator used for providing assisted ventilation to patients. It is classified as a Class II medical device under the FDA product code BTM and regulation number 868.5915.

This device received FDA 510(k) clearance (K912625) on August 2, 1991, and is substantially equivalent to a predicate device. It is supplied non-sterile and intended for single-use in emergency and clinical settings, with no MRI safety information provided in the data.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK912625 Date2 Aug 1991ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • 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)

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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Questions

  • What is the MOUTH TO MASK RESUSCITATOR used for?

    It is a manual emergency ventilator used for providing assisted ventilation to patients in emergency and clinical settings, as it delivers breaths when spontaneous breathing is inadequate or absent.

  • How is the MOUTH TO MASK RESUSCITATOR supplied and is it sterile?

    The device is supplied non-sterile, meaning it does not arrive in a sterile condition and requires cleaning or disinfection before use if sterility is needed, though it is intended for single-use only.

  • Is the MOUTH TO MASK RESUSCITATOR designed for single-use or reuse?

    It is intended for single-use in emergency and clinical settings, meaning it should be discarded after one patient encounter to prevent cross-contamination and ensure safety.

  • What regulatory pathway was used for the MOUTH TO MASK RESUSCITATOR?

    It received FDA 510(k) clearance (K912625) on August 2, 1991, demonstrating substantial equivalence to a predicate device under the traditional review pathway.

  • What classification and product code apply to the MOUTH TO MASK RESUSCITATOR?

    It is classified as a Class II medical device under FDA product code BTM and regulation number 868.5915, which governs manual emergency ventilators.