PMX Disposable Bag Mask Resuscitator

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

510(k) Number

K014071 ↗

FDA Product Code

BTM

Device Class

Class II

Regulation

21 CFR Part 868.5915

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Schuco Mist and Schuco Deluxe Mist

  Class II

  FDA 510(k) K051260 Active Cleared 15 Sep 2005

• Mass Spectrometer-Medspect II

  Class I

  FDA 510(k) K810938 Active Cleared 23 Apr 1981

• Gomco Suction Pump Cabinet Change

  Class II

  FDA 510(k) K810490 Active Cleared 13 Mar 1981

• Bear Cub Infant Pressure Ventilator

  Class II

  FDA 510(k) K955865 Active Cleared 6 Aug 1996

• Ahp 300, Emergency Portable Ventilator

  Class II

  FDA 510(k) K132021 Active Cleared 2 Apr 2014

• Babybird Ventilator, Portable Lifecare Ventilator, External Pressure Limiter, Volume Ventilator with Pressure Limit

  Class II

  FDA 510(k) K972203 Active Cleared 6 Nov 1997

See all devices from Allied Healthcare Products, Inc. →

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

  The PMX Disposable Bag Mask Resuscitator is designed for manual positive pressure ventilation during resuscitation or patient transport. It delivers controlled airflow to a patient’s airway when immediate ventilation support is required, such as in emergency rooms, pre-hospital settings, or operating rooms. The bag-and-valve assembly allows clinicians to manually compress the bag to provide oxygen or air, ensuring effective breathing assistance.

• Is the PMX Disposable Bag Mask Resuscitator single-use or reusable?

  The PMX Disposable Bag Mask Resuscitator is a single-use device. It is supplied sterile and intended for one-time use per patient to prevent cross-contamination and maintain infection control standards in clinical environments. Discarding after use aligns with its design for safe, hygienic resuscitation procedures.

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

  The PMX Disposable Bag Mask Resuscitator should be stored according to the manufacturer’s guidelines for single-use medical devices. This typically involves keeping it in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Proper storage ensures the device remains sterile and functional until use.

• What regulatory clearance does the PMX Disposable Bag Mask Resuscitator hold?

  The PMX Disposable Bag Mask Resuscitator holds a 510(k) clearance (K014071) from the FDA, demonstrating substantial equivalence to a predicate device. This clearance confirms it meets regulatory requirements for emergency manual resuscitators under Class II classification. The device is authorized for use in clinical settings where manual ventilation is required.

• Are there different sizes or models available for the PMX Disposable Bag Mask Resuscitator?

  The provided data does not specify multiple sizes or models for the PMX Disposable Bag Mask Resuscitator. However, it is classified under emergency manual resuscitators with multiple FDA registration numbers, which may indicate variations in packaging or minor design adaptations. For exact specifications, refer to the manufacturer’s product documentation or contact Allied Healthcare Products, Inc.