510(k) · Cleared
ClearedPressure Release Valve W/Audible, Model PRV 20/40/60; with T6 Adapter, Model PRV 120/140/160; T6 Adapter, Model T6-100
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 Mar 25, 2010 as substantially equivalent to K040366 (Fisher & Paykel Healthcare, Ltd., 2004) after a 303-day review. Its family tree reaches back 2 generations to 1983. 1 later device descends from it.
- Decided
- Mar 25, 2010
- Review
- 303 days
- Class
- Class II
- Product code
- CBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K831246 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK831246 Whistler in-Line Pressure Release ValveAirlife, Inc. · 1983
- 1 generation backK040366 Pressure Manifold, Model BC 110Fisher & Paykel Healthcare, Ltd. · 2004
- This deviceK091538 Pressure Release Valve W/Audible, Model PRV 20/40/60; with T6…Wet Nose Technologies, LLC · 2010
- Descendant · cites it directly · 0 of its ownK111191 Audible Pressure Release Valve with Humidifier Adapter / and Oxygen…Wet Nose Technologies, LLC · 2011
Most influential descendants
Showing 1 of 1 · See all- K111191Audible Pressure Release Valve with Humidifier Adapter / and Oxygen NippleWet Nose Technologies, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831246 | Whistler in-Line Pressure Release Valve | Airlife, Inc. | 1983 | — |
| −1 | K040366 | Pressure Manifold, Model BC 110 | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| 0 (this device) | K091538 | Pressure Release Valve W/Audible, Model PRV 20/40/60; with T6 Adapter, Model… | Wet Nose Technologies, LLC | 2010 | — |
| +1 | K111191 | Audible Pressure Release Valve with Humidifier Adapter / and Oxygen Nipple | Wet Nose Technologies, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 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 |
|---|---|---|---|
| * | K040366 | Pressure Manifold, Model BC 110Summary page 1…C. Predicate Device: Fisher & Paykel BC1 10I Pressure Manifold Predicate 5 10O(k) #:K040366 Predicate product code: CBP D. Device Description The Pressure Release Valve (PRV… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111191 | Audible Pressure Release Valve with Humidifier Adapter / and Oxygen Nipple | 2011 | 0 |
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 27 years and passes through 3 companies; a new generation was cleared every 20.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K111191 (Wet Nose Technologies, LLC, 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K040366.
How does its category compare?
All CBP devicesCBP Valve, Non-Rebreathing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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) Pressure Release Valve is intended for use with 'positive pressute' breathing gas delivery systems (e.g., High Flow Nasal Cammila or Bubble CPAP type systems) for pediatric/infants patients utilizing continuous flow systems with flow rates greater than 0 L/min and up to, and including 15 L/min. The device is intended for use when a disposable, low pressure (20 cm H-20 +/- 4 cm H20 activation), audible, nion-adjustable…
Read the full statement (141 words)
The Wet Nose Technologies (WNT) Pressure Release Valve is intended for use with 'positive pressute' breathing gas delivery systems (e.g., High Flow Nasal Cammila or Bubble CPAP type systems) for pediatric/infants patients utilizing continuous flow systems with flow rates greater than 0 L/min and up to, and including 15 L/min. The device is intended for use when a disposable, low pressure (20 cm H-20 +/- 4 cm H20 activation), audible, nion-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/K091538 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091538: Pressure Release Valve W/Audible, Model PRV 20/40/60; with T6 Adapter, Model PRV 120/140/160; T6 Adapter, Model T6-100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091538
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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