# K110713: Waterpap Valve

- Pathway: 510(k) (Traditional)
- Applicant: Airways Development, LLC
- Decided: Sep 12, 2011 after 181 days
- Product code: BYE (Attachment, Breathing, Positive End Expiratory Pressure)
- Device class: 2
- Regulation: 21 CFR 868.5965
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K902062 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090317: Babi*Plus Bubble Pap Valve, A Plus Medical (2009) Summary page 1.

## Recalls of this device
- Sep 24, 2015 · Class II · Z-0552-2016: Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a review with their supplier it could not be determined if this was an isolated incident or if

## Indications for use
The WaterPAP 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/K110713
Methodology: https://510kreport.com/methodology