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Lifeguard Vent Mask

by Breath of Life, Inc.

510(k) K883383

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 NumberK883383 Date21 Nov 1988ClearedStatusActive

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  • Withdrawn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
CBP
Device Class
Class II
Regulation
21 CFR Part 868.5870
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Lifeguard Vent Mask is a Valve, Non-Rebreathing, designed to facilitate ventilation during resuscitation or anesthesia procedures. It ensures one-way airflow by preventing exhaled gases from re-entering the patient’s airway, thereby maintaining oxygen delivery and minimizing contamination risk. This device is intended for use with manual ventilation sources, such as ambubags or manual resuscitation devices, to deliver controlled breaths to patients in critical care settings.

The Lifeguard Vent Mask is supplied as a single-use, non-sterile device, intended for use in clinical environments where ventilation support is required. It is classified under FDA regulation 868.5870 and was granted FDA 510(k) clearance (K883383) in 1988 under the Anesthesiology advisory committee. The device is not MRI-safe and must be stored in a clean, dry environment until use. No additional regulatory authorizations beyond the 510(k) clearance are referenced in the available data.

Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Lifeguard Vent Mask designed for?

    The Lifeguard Vent Mask is a non-rebreathing valve specifically designed to facilitate ventilation during resuscitation or anesthesia procedures. It ensures one-way airflow by preventing exhaled gases from re-entering the patient’s airway, which helps maintain consistent oxygen delivery and reduces contamination risk. This makes it ideal for use with manual ventilation sources like ambubags or resuscitation devices in critical care settings.

  • Is the Lifeguard Vent Mask sterile and single-use?

    The Lifeguard Vent Mask is supplied as a single-use device and is non-sterile. It is intended for clinical environments where ventilation support is required, but it is not pre-sterilized. Always follow facility protocols for cleaning and handling non-sterile medical devices before use.

  • How should the Lifeguard Vent Mask be stored?

    The device must be stored in a clean, dry environment until use. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these conditions could compromise its integrity. Ensure it is kept in its original packaging or a sealed container to prevent contamination.

  • Can the Lifeguard Vent Mask be reused?

    No, the Lifeguard Vent Mask is explicitly designed for single-use only. Reusing it poses risks of contamination, malfunction, or compromised performance, which could endanger patient safety. Always use a new mask for each patient or procedure.

  • What regulatory approval does the Lifeguard Vent Mask hold?

    The Lifeguard Vent Mask holds FDA 510(k) clearance (K883383) under the Anesthesiology advisory committee, with a classification under FDA regulation 868.5870. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. regulatory standards for non-rebreathing valves.