# K111191: Audible Pressure Release Valve with Humidifier Adapter / and Oxygen Nipple

- Pathway: 510(k) (Special)
- Applicant: Wet Nose Technologies, LLC
- Decided: Jul 28, 2011 after 91 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K831246 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091538: Pressure Release Valve W/Audible, Model PRV 20/40/60; with T6 Adapter, Model PRV 120/140/160; T6 Adapter, Model T6-100, Wet Nose Technologies, LLC (2010) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K111191
Methodology: https://510kreport.com/methodology