Cleared Traditional

K950771 - DISPOSABLE ADHESIVE FACE MASK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K950771 · Advanced Warming Systems, Inc. · Anesthesiology device
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Mar 1995
Decision
382d
Days
Class 1
Risk

K950771 is an FDA 510(k) clearance for the DISPOSABLE ADHESIVE FACE MASK. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Advanced Warming Systems, Inc. (Lubbock, US). The FDA issued a Cleared decision on March 10, 1995 after a review of 382 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5550 - 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 Advanced Warming Systems, Inc. devices

Submission Details

510(k) Number K950771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1994
Decision Date March 10, 1995
Days to Decision 382 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
243d slower than avg
Panel avg: 139d · This submission: 382d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSJ Mask, Gas, Anesthetic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5550
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.