Mouth to Mask Resuscitator

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

Full name

Lifeguard Mouth to Mask Resuscitator

510(k) Number

K881086 ↗

FDA Product Code

BTM

Device Class

Class II

Regulation

21 CFR Part 868.5915

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Monopolar Electrode

  Class II

  FDA 510(k) K915296 Active Cleared 3 Sep 1992

• Single Use Manual Resuscitator

  Class II

  FDA 510(k) K881087 Active Cleared 14 Apr 1988

• Regulator Oxygen Mechanical

  Class I

  FDA 510(k) K863711 Active Cleared 27 Jan 1987

• Levy Articulating Retractor

  Class I

  FDA 510(k) K920471 Active Cleared 23 Jun 1992

• Lifeguard Gas Sampling Line for Mass Spectrometry

  Class I

  FDA 510(k) K880959 Active Cleared 14 Apr 1988

• Regulator Flowmeter

  Class I

  FDA 510(k) K915505 Active Cleared 22 Apr 1992

See all devices from Lifeguard Medical Products, Inc. →

• What is the Lifeguard Mouth to Mask Resuscitator used for?

  The Lifeguard Mouth to Mask Resuscitator is designed specifically for cardiopulmonary resuscitation (CPR) to assist in delivering oxygen to a patient during emergency resuscitation. It acts as a barrier between the rescuer’s mouth and the patient’s airway, reducing the risk of cross-contamination while providing manual ventilation. It is not intended for continuous mechanical ventilation but is ideal for pre-hospital or in-hospital emergency scenarios where quick, manual ventilation support is required.

• Is the Lifeguard Mouth to Mask Resuscitator sterile?

  No, the Lifeguard Mouth to Mask Resuscitator is supplied as a non-sterile single-use device. Since it is intended for emergency resuscitation, sterility is not required for its intended use, but proper hand hygiene and barrier precautions (e.g., gloves) should still be followed by the rescuer to minimize infection risk.

• How is the Lifeguard Mouth to Mask Resuscitator supplied?

  The device is supplied as a single-use item, meaning each unit is intended for one-time use only before disposal. This ensures hygiene and safety in emergency resuscitation scenarios. It is packaged individually for immediate access in critical situations.

• What regulatory approval does the Lifeguard Mouth to Mask Resuscitator hold?

  The Lifeguard Mouth to Mask Resuscitator has received FDA 510(k) clearance (K881086), confirming it is substantially equivalent to a predicate device under FDA’s classification system. It is regulated under 21 CFR 868.5915 and falls under the product code BTM for manual emergency resuscitators. No third-party certification (e.g., ISO) is indicated.

• Can the Lifeguard Mouth to Mask Resuscitator be reused?

  No, the device is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise the integrity of the barrier and increase infection risks. Each unit should be discarded after one use in accordance with emergency resuscitation protocols.