Cleared Traditional

K913972 - STAR SYNC, MODIFICATION

K913972 is an FDA 510(k) clearance for STAR SYNC, 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 126-day FDA review.

K913972 · Infrasonics Corp. · Anesthesiology device
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Jan 1992
Decision
126d
Days
Class 2
Risk

K913972 is an FDA 510(k) clearance for the STAR SYNC, 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 9, 1992 after a review of 126 days - within the typical 510(k) review window.

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 Infrasonics Corp. devices

FDA 510(k) Submission Details - K913972

510(k) Number K913972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1991
Decision Date January 09, 1992
Days to Decision 126 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
14d faster than avg
Panel avg: 140d · This submission: 126d
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 K913972.
BEAR 7 VENTILATOR
K912619 · Bear Medical Systems, Inc. · Jun 1992
HAYEK OSCILLATOR, MODIFICATION
K921726 · Respironics, Inc. · Apr 1992
LIFECARE REMOTE ALARM II
K913423 · Lifecare Services, Inc. · Jan 1992
BIRD NEBULIZATION SYNCHRONIZER
K911336 · Bird Products Corp. · Nov 1991
VENTILATOR STAND
K914485 · Bird Products Corp. · Oct 1991
NARKOMED AV-E VENTILATOR
K912533 · Draeger Medical, Inc. · Jul 1991