Infant Disposable Bag Mask Resuscitator

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

510(k) Number

K922819 ↗

FDA Product Code

BTM

Device Class

Class II

Regulation

21 CFR Part 868.5915

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Lspi Automatic Ventilator, Model AV3000-100

  Class II

  FDA 510(k) K941871 Active Cleared 9 Jan 1995

• Spiros

  Class II

  FDA 510(k) K915564 Active Cleared 30 Jan 1992

• Lspi Pressure Regulator

  Class I

  FDA 510(k) K936187 Active Cleared 27 Jan 1994

• Lsp Minilator

  Class I

  FDA 510(k) K860516 Active Cleared 21 Feb 1986

• Autovac

  Class II

  FDA 510(k) K921107 Active Cleared 17 Sep 1992

• Lspi Automatic Ventilator

  Class II

  FDA 510(k) K932200 Active Cleared 24 Nov 1993

See all devices from Life Support Products, Inc. →

• What is the Infant Disposable Bag Mask Resuscitator used for?

  The Infant Disposable Bag Mask Resuscitator is designed specifically for manual ventilation of infants during resuscitation. It delivers oxygen or air via a self-inflating bag connected to a mask, allowing controlled breaths to support or restore spontaneous respiration in pediatric patients. This is critical in emergency medical settings where immediate respiratory support is required, such as in emergency rooms, pre-hospital environments, or operating rooms.

• Is this device single-use or reusable?

  This device is intended for single-use only. It is packaged individually for each patient to ensure hygiene and prevent cross-contamination. After use, the device should be discarded to comply with infection control protocols.

• What is the sterility status of the Infant Disposable Bag Mask Resuscitator?

  The Infant Disposable Bag Mask Resuscitator is supplied as a non-sterile device. While it is packaged for individual patient use, it is not sterile and should not be considered for sterile procedures. Proper hand hygiene and aseptic techniques should be followed when handling the device.

• Where can this device be used?

  This device is intended for use in clinical settings where emergency respiratory support is required, including emergency rooms, pre-hospital environments (such as ambulances), and operating rooms. It is not designed for use in non-emergency or non-clinical settings.

• How should the Infant Disposable Bag Mask Resuscitator be stored?

  The device should be stored in its original, unopened packaging to maintain its integrity and prevent contamination. Keep it in a clean, dry environment away from direct sunlight or extreme temperatures. Ensure the packaging remains sealed until immediate use to preserve the device’s condition for single-use applications.