Cleared Traditional

K091538 - PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60

Also marketed or referenced as:
WITH T6 ADAPTER, MODEL PRV 120/140/160 T6 ADAPTER, MODEL T6-100

K091538 is an FDA 510(k) clearance for PRESSURE RELEASE VALVE W/AUDIBLE, manufactured by Wet Nose Technologies, LLC. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K091538 · Wet Nose Technologies, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
303d
Days
Class 2
Risk

K091538 is an FDA 510(k) clearance for the PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Wet Nose Technologies, LLC (Los Angeles, US). The FDA issued a Cleared decision on March 25, 2010 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K091538

510(k) Number K091538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2009
Decision Date March 25, 2010
Days to Decision 303 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 140d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CBP Valve, Non-rebreathing

All 86
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K091538.
AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
K111191 · Wet Nose Technologies, LLC · Jul 2011
CPR FACE MASK
K102299 · Genuine First Aid, LLC · Mar 2011
CPR MASK
K083418 · Firstar Healthcare Co., Ltd. · Jul 2010
OXYGEN DEMAND VALVE
K082345 · Bpr Medical, Ltd. · Mar 2009
MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
K081516 · Medsource International, LLC · Aug 2008
LIV MEDICA CPR FACE MASK
K052458 · Liv Medica Products Pvt. , Ltd. · Jul 2006