Cleared Traditional

K931355 - WHISPER O2

K931355 is the FDA 510(k) clearance for WHISPER O2 by Trilogic Corp.. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 373-day FDA review.

K931355 · Trilogic Corp. · Anesthesiology device
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Mar 1994
Decision
373d
Days
Class 2
Risk

K931355 is an FDA 510(k) clearance for the WHISPER O2. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Trilogic Corp. (Littleton, US). The FDA issued a Cleared decision on March 25, 1994 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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.

View all Trilogic Corp. devices

Submission Details

510(k) Number K931355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date March 25, 1994
Days to Decision 373 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
233d slower than avg
Panel avg: 140d · This submission: 373d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 67
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K931355.
VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
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MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM
K983777 · Invacare Corp. · Dec 1998
MOBILAIRE V & III PRO2 OXYGEN SENSORS FEATURES
K924818 · Invacare Corp. · Aug 1993
MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS
K914488 · Invacare Corp. · Sep 1992
MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON
K904087 · Invacare Corp. · Oct 1990