# K031434: Bawmed E-Z Bag Resuscitator

- Pathway: 510(k) (Traditional)
- Applicant: Bawmed UK
- Decided: Feb 6, 2004 after 276 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 Bawmed E-Z Bag Resuscitators are manual resuscitators incorporating a bag and valve, intended to provide respiratory support to patients suffering from respiratory distress. The infant model is intended for patients weighing between 5 to 12 kgs, the child model is intended for patients weighing between 10 to 30 kgs, and the adult model is intended for patients weighing more than 30 kgs approximate weight. The Bawmed E-Z Bag Resuscitator provided in reusable models and in the disposable models.

Source page: https://510kreport.com/device/K031434
Methodology: https://510kreport.com/methodology