Cleared Traditional

K951043 - AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK (FDA 510(k) Clearance)

Class I Anesthesiology device.

K951043 · Promedic, Inc. · Anesthesiology device
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Jun 1995
Decision
92d
Days
Class 1
Risk

K951043 is an FDA 510(k) clearance for the AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Promedic, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 7, 1995 after a review of 92 days - within the typical 510(k) review window.

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. 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 Promedic, Inc. devices

Submission Details

510(k) Number K951043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1995
Decision Date June 07, 1995
Days to Decision 92 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
47d faster than avg
Panel avg: 139d · This submission: 92d
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.