510(k) · Cleared
ClearedAudible Pressure Release Valve with Humidifier Adapter / and Oxygen Nipple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wet Nose Technologies, LLC · CBP Valve, Non-Rebreathing
Cleared on Jul 28, 2011 as substantially equivalent to K091538 (Wet Nose Technologies, LLC, 2010) after a 91-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Jul 28, 2011
- Review
- 91 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K831246 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK831246 Whistler in-Line Pressure Release ValveAirlife, Inc. · 1983
- 2 generations backK040366 Pressure Manifold, Model BC 110Fisher & Paykel Healthcare, Ltd. · 2004
- 1 generation backK091538 Pressure Release Valve W/Audible, Model PRV 20/40/60; with T6…Wet Nose Technologies, LLC · 2010
- This deviceK111191 Audible Pressure Release Valve with Humidifier Adapter / and Oxygen…Wet Nose Technologies, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K831246 | Whistler in-Line Pressure Release Valve | Airlife, Inc. | 1983 | — |
| −2 | K040366 | Pressure Manifold, Model BC 110 | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −1 | K091538 | Pressure Release Valve W/Audible, Model PRV 20/40/60; with T6 Adapter, Model… | Wet Nose Technologies, LLC | 2010 | — |
| 0 (this device) | K111191 | Audible Pressure Release Valve with Humidifier Adapter / and Oxygen Nipple | Wet Nose Technologies, LLC | 2011 | — |
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 CBP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CBP device
- #1 K241366 QualityFlow O2 Series (QualityFLOW O2)…score 8.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K091538 | Pressure Release Valve W/Audible, Model PRV 20/40/60; with T6 Adapter, Model PRV…Summary page 1…C. Predicate Device: Wet Nose Technologies Pressure Release Valve, 20 cm H20 Predicate 5 10O(k) #: K091538 Predicate product code: CBP Page I of 3 D. Device Descript… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All CBP devicesCBP Valve, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CBP
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CBP
129in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBP
No recall names CBP since 2007.
Adverse event reports per year · CBP
1in 2021
MAUDE reports naming product code CBP, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 3 | 129 | 0 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Wet Nose Technologies (WNT) Audible Pressure Release Valve (APRV) is intended for use with 'positive pressure' breathing gas delivery systems (e.g., High Flow nasal Cannula or bubble OPAP type systems) for pediatric/infants patients utilizing continuous flow systems with flow rates greater than 0 L/min and up, and including 15 L/min. The device is intended for use when a disposable, low pressure (10 cm H20 +/-2 cm H20), low-moderate pressure (20 cm…
Read the full statement (158 words)
The Wet Nose Technologies (WNT) Audible Pressure Release Valve (APRV) is intended for use with 'positive pressure' breathing gas delivery systems (e.g., High Flow nasal Cannula or bubble OPAP type systems) for pediatric/infants patients utilizing continuous flow systems with flow rates greater than 0 L/min and up, and including 15 L/min. The device is intended for use when a disposable, low pressure (10 cm H20 +/-2 cm H20), low-moderate pressure (20 cm H20 +/- 4cm H20) or moderate-high pressure (40 cm H20 +/- 8 cm H20), audible, non-adjustable pressure relief valve is needed to be placed upstream of the patient in-line with the circuit to protect the patient from excessive inspiratory pressure in event of a downstream occlusion or an increase of system pressure above the relief pressure. Intended to alert the healthcare provider(s) of a need to take corrective action to reduce system pressure, the device emits an audible sound when circuit pressure is above relief pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111191: Audible Pressure Release Valve with Humidifier Adapter / and Oxygen Nipple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111191
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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