Cleared Traditional

K953295 - ANESTHESIA FACE MASK

K953295 is the FDA 510(k) clearance for ANESTHESIA FACE MASK by Mallinckrodt Medical. It is a Class 1 Anesthesiology device (product code BSJ) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K953295 · Mallinckrodt Medical · Anesthesiology device
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Aug 1995
Decision
28d
Days
Class 1
Risk

K953295 is an FDA 510(k) clearance for the ANESTHESIA FACE MASK. Classified as Mask, Gas, Anesthetic (product code BSJ), Class I - General Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on August 11, 1995 after a review of 28 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mallinckrodt Medical devices

Submission Details

510(k) Number K953295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1995
Decision Date August 11, 1995
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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.

Regulatory Peers - BSJ Mask, Gas, Anesthetic

All 20
Devices cleared under the same product code (BSJ) and FDA review panel - the closest regulatory comparables to K953295.
AMBU DISPOSABLE FACE MASK
K932014 · Ambu, Inc. · Jun 1993
RESPIRONICS SEALEASY II
K890795 · Respironics, Inc. · Apr 1989
MODIFIED CUSHION-FLEX(TM)
K890108 · Life Design Systems, Inc. · Jan 1989
CUSHION FLEX(TM)
K884387 · Life Design Systems, Inc. · Nov 1988
MP-XMM DISPOSABLE FACE MASK
K862781 · Medipart Jerry Alexander · Aug 1986
MP-XML DISPOSABLE FACE MASK
K862782 · Medipart Jerry Alexander · Aug 1986