Cleared Traditional

AIROX AXR. 1A (K901953) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 139d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 63
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K901953.
SERVO GRAPHICS
K923444 · Siemens Medical Solutions USA, Inc. · Mar 1993
MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT
K925262 · Merit Medical Systems, Inc. · Jan 1993
HAYEK OSCILLATOR, MODIFICATION
K921726 · Respironics, Inc. · Apr 1992
MODIFIED PERMCATH TRAY (2ND SUBMISSION)
K895779 · Quinton, Inc. · Dec 1989
BABYBIRD 2 VENTILATOR
K820132 · 3M Company · Jan 1982
HEWLETT-PACKARD VENTILATOR
K810893 · Hewlett-Packard Co. · Jun 1981