510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K091538Substantially Equivalent

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, Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091538 is the FDA 510(k) clearance record for PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100, a class II device, cleared for Wet Nose Technologies, LLC on under FDA product code CBP (Valve, Non-Rebreathing). FDA records list 2 510(k) clearances for Wet Nose Technologies, LLC, from to . As of , FDA records show no recalls naming K091538.

Clearance record

Decision date
Received
(303 days to decision)
Product code
CBP Valve, Non-Rebreathing
Regulation
21 CFR 868.5870
Device class
Class II
Review panel
Anesthesiology
Applicant
Wet Nose Technologies, LLC 3750 2nd Ave., Los Angeles CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CBP

Trailing 12 months

FDA records hold no clearances under product code CBP in the trailing twelve months.

FDA records show no clearances under product code CBP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260