Cleared Traditional

K831246 - WHISTLER IN-LINE PRESSURE RELEASE VALVE

K831246 is an FDA 510(k) clearance for WHISTLER IN-LINE PRESSURE RELEASE VALVE, manufactured by Airlife, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K831246 · Airlife, Inc. · Anesthesiology device
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Jul 1983
Decision
99d
Days
Class 2
Risk

K831246 is an FDA 510(k) clearance for the WHISTLER IN-LINE PRESSURE RELEASE VALVE. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 99 days - within the typical 510(k) review window.

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

View all Airlife, Inc. devices

FDA 510(k) Submission Details - K831246

510(k) Number K831246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1983
Decision Date July 26, 1983
Days to Decision 99 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 140d · This submission: 99d
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 44
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K831246.
INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR
K870253 · Intertech Resources, Inc. · Mar 1987
RESCUE VALVE
K833748 · Respironics, Inc. · Dec 1983
RESUSCITATION VALVE
K832868 · Boehringer Laboratories · Sep 1983
CM 3
K810348 · Instrumentation Industries, Inc. · Feb 1981
RETARD VALVE 3-STACK #M-515
K791907 · Mem Medical, Inc. · Oct 1979
RETARD VALVE 3-STACK #M-514
K791908 · Mem Medical, Inc. · Oct 1979