# K091538: Pressure Release Valve W/Audible, Model PRV 20/40/60; with T6 Adapter, Model PRV 120/140/160; T6 Adapter, Model T6-100

- Pathway: 510(k) (Traditional)
- Applicant: Wet Nose Technologies, LLC
- Decided: Mar 25, 2010 after 303 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: 2 generations back to K831246 (1983). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040366: Pressure Manifold, Model BC 110, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.

## Most influential descendants
- K111191: Audible Pressure Release Valve with Humidifier Adapter / and Oxygen Nipple (2011), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K091538
Methodology: https://510kreport.com/methodology