510(k) · Cleared
Recalled · Class II · 2015Waterpap Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Airways Development, LLC · BYE Attachment, Breathing, Positive End Expiratory Pressure
Cleared on Sep 12, 2011 as substantially equivalent to K090317 (A Plus Medical, 2009) after a 181-day review. Its family tree reaches back 3 generations to 1990. It has been recalled once.
- Decided
- Sep 12, 2011
- Review
- 181 days
- Class
- Class II
- Product code
- BYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902062 (1990). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK902062 Peep ValveHudson Oxygen Therapy Sales Co. · 1990
- 2 generations backK082092 Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve…Galemed Corp. · 2008
- 1 generation backK090317 Babi*Plus Bubble Pap ValveA Plus Medical · 2009
- This deviceK110713 Waterpap ValveAirways Development, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902062 | Peep Valve | Hudson Oxygen Therapy Sales Co. | 1990 | — |
| −2 | K082092 | Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable… | Galemed Corp. | 2008 | — |
| −1 | K090317 | Babi*Plus Bubble Pap Valve | A Plus Medical | 2009 | — |
| 0 (this device) | K110713 | Waterpap Valve | Airways Development, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090317 | Babi*Plus Bubble Pap ValveSummary page 1…edicate Device: Babi*Plus Bubble PAP Valve A Plus Medical (Manufacturer) 5 10(k) Number: K0903 17 Device Description: The WaterPAP Valve is an infant positive end expiratory pressure device used to increase end lung pressure a… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2015 | Class II | Z-0552-2016 | Nonconforming Material/Component | 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 the whole lot is impacted. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All BYE devicesBYE Attachment, Breathing, Positive End Expiratory Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BYE
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · BYE
117in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BYE
1in 2015
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BYE
7in 2025
MAUDE reports naming product code BYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 4 | 8 |
| 2008 | 1 | — | 2 | 3 |
| 2009 | 3 | 155 | 0 | 1 |
| 2010 | 1 | — | 0 | 4 |
| 2011 | 3 | 117 | 0 | 2 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 8 |
| 2015 | 0 | — | 1 | 4 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 11 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110713: Waterpap Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110713
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026