# K014071: PMX Disposable Bag Mask Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Allied Healthcare Products, Inc.
- Decided: Oct 1, 2002 after 295 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The PMX Disposable Bag Mask Resuscitator are manual resuscitators incorporating a bag and valve, intended to provide emergency ventilation or ventilation during patient transport. The chld model is intended for patients weighting between 10 and 40 kg and the adult model is intended for patients weighting more than 40 kg approximate weight.

Source page: https://510kreport.com/device/K014071
Methodology: https://510kreport.com/methodology