# K940581: Bageasy (R) Iii Child/Infant Dispos Man Resuscitators

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: May 6, 1994 after 87 days
- Product code: BTM (Ventilator, Emergency, Manual (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5915
- Recalls of this device: 2 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jun 22, 2010 · Not classified · Z-2333-2010: This recall was initiated after Westmed, Inc. became aware of a potential for disconnection at the patient port retention ring assembly of the Bag Easy manual resuscitation device.
- Jun 22, 2010 · Not classified · Z-2332-2010: This recall was initiated after Westmed, Inc. became aware of a potential for disconnection at the patient port retention ring assembly of the Bag Easy manual resuscitation device.

Source page: https://510kreport.com/device/K940581
Methodology: https://510kreport.com/methodology