Cleared Traditional

K905272 - ADULT STAR, MODIFICATION

K905272 is an FDA 510(k) clearance for ADULT STAR, manufactured by Infrasonics Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K905272 · Infrasonics Corp. · Anesthesiology device
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Jan 1991
Decision
68d
Days
Class 2
Risk

K905272 is an FDA 510(k) clearance for the ADULT STAR, MODIFICATION. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Infrasonics Corp. (San Diego, US). The FDA issued a Cleared decision on January 30, 1991 after a review of 68 days - a notably fast clearance 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: 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 Infrasonics Corp. devices

FDA 510(k) Submission Details - K905272

510(k) Number K905272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1990
Decision Date January 30, 1991
Days to Decision 68 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
72d faster than avg
Panel avg: 140d · This submission: 68d
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 326
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K905272.
BABYLOG 8000 INFANT VENTILATOR
K903089 · Drager, Inc. · Jun 1991
OHMEDA 7810 ANESTHESIA VENTILATOR
K910847 · Ohmeda Medical · May 1991
MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR
K902405 · Mallinckrodt Medical · Mar 1991
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
K902506 · Puritan Bennett Corp. · Jan 1991
AIROX AXR. 1A
K901953 · Ferguson Medical · Jan 1991
CONTINUOUS VOLUME VENTILATOR MODEL LP10
K903010 · Aequitron Medical, Inc. · Nov 1990