Cleared Traditional

K901953 - AIROX AXR. 1A

K901953 is an FDA 510(k) clearance for AIROX AXR. 1A, manufactured by Ferguson Medical. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K901953 · Ferguson Medical · Anesthesiology device
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Jan 1991
Decision
246d
Days
Class 2
Risk

K901953 is an FDA 510(k) clearance for the AIROX AXR. 1A. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on January 2, 1991 after a review of 246 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Ferguson Medical devices

FDA 510(k) Submission Details - K901953

510(k) Number K901953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1990
Decision Date January 02, 1991
Days to Decision 246 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 140d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 395
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K901953.
MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR
K902405 · Mallinckrodt Medical · Mar 1991
ADULT STAR, MODIFICATION
K905272 · Infrasonics Corp. · Jan 1991
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
K902506 · Puritan Bennett Corp. · Jan 1991
CONTINUOUS VOLUME VENTILATOR MODEL LP10
K903010 · Aequitron Medical, Inc. · Nov 1990
MODEL LP6 VENTILATOR, MODIFICATION
K905244 · Aequitron Medical, Inc. · Nov 1990
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
K902084 · Ohmeda Medical · Oct 1990