Cleared Traditional

K950771 - DISPOSABLE ADHESIVE FACE MASK

K950771 is an FDA 510(k) clearance for DISPOSABLE ADHESIVE FACE MASK, manufactured by Advanced Warming Systems, Inc.. The device is a Class 1 Anesthesiology device with product code BSJ cleared through the Traditional 510(k) pathway after a 382-day FDA review.

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.

FDA 510(k) Submission Details - K950771

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
242d slower than avg
Panel avg: 140d · This submission: 382d
Pathway characteristics
Predicate-based equivalence.

BSJ Device Classification - Class 1, General Controls

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.

Regulatory Peers - BSJ Mask, Gas, Anesthetic

All 50
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K950771.
ANESTHESIA FACE MASK
K953295 · Mallinckrodt Medical · Aug 1995
BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK
K952689 · Owens-Brigam Medical Co. · Jul 1995
AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
K951043 · Promedic, Inc. · Jun 1995
MASK, GAS, ANESTHETIC
K945894 · Hans Rudolph, Inc. · Jan 1995
DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK
K945440 · Fvtnks · Nov 1994
DISPOSABLE, PREFORMED FACE MASK
K944157 · Meridian Medical Systems, Inc. · Oct 1994
K950771 · DISPOSABLE ADHESIVE FACE MASK
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