# K112852: Babi Plus Neonatal Resuscitation Bag

- Pathway: 510(k) (Traditional)
- Applicant: A Plus Medical
- Decided: Jan 13, 2012 after 87 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
Longest line of descent: 2 generations back to K902062 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082092: Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep Valve, Galemed Corp. (2008) Summary page 1.

## Indications for use
Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.

Source page: https://510kreport.com/device/K112852
Methodology: https://510kreport.com/methodology