Cleared Traditional

K091538 - PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60 (FDA 510(k) Clearance)

Also includes:
WITH T6 ADAPTER, MODEL PRV 120/140/160 T6 ADAPTER, MODEL T6-100

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K091538 · Wet Nose Technologies, LLC · Anesthesiology device
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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.

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Submission Details

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
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 139d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.