# K090317: Babi*Plus Bubble Pap Valve

- Pathway: 510(k) (Traditional)
- Applicant: A Plus Medical
- Decided: May 20, 2009 after 100 days
- Product code: BYE (Attachment, Breathing, Positive End Expiratory Pressure)
- Device class: 2
- Regulation: 21 CFR 868.5965
- 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.
1 later device descends from it; 1 cites it directly.
0 of 5 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.
- K902062: Peep Valve, Hudson Oxygen Therapy Sales Co. (1990) Summary page 1.
- (no number) Water Seal PEEP Valve: named in the summary without a submission number
- (no number) LIFESAVER® PEEP Valve Models 5383 and 5385: named in the summary without a submission number

## Most influential descendants
- K110713: Waterpap Valve (2011), 0 descendants of its own

## Indications for use
The Babi*Plus Bubble PAP Valve is a single patient use positive end expiratory pressure valve for use with infant patients weighing < 10 Kg in hospital environments to increase end lung pressure above atmospheric in constant flow conditions.

Source page: https://510kreport.com/device/K090317
Methodology: https://510kreport.com/methodology