Cleared Traditional

K920954 - AIR STAR

K920954 is an FDA 510(k) clearance for AIR STAR, manufactured by Infrasonics Corp.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K920954 · Infrasonics Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
159d
Days
Class 2
Risk

K920954 is an FDA 510(k) clearance for the AIR STAR. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Infrasonics Corp. (San Diego, US). The FDA issued a Cleared decision on August 3, 1992 after a review of 159 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - 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 - K920954

510(k) Number K920954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1992
Decision Date August 03, 1992
Days to Decision 159 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
19d slower than avg
Panel avg: 140d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTI Device Classification - Class 2, Special Controls

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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 - BTI Compressor, Air, Portable

All 30
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K920954.
DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER
K931015 · Devilbiss Health Care, Inc. · Sep 1993
SAM ST
K913097 · Ferguson Medical · Dec 1992
NEBULIZER SYSTEM
K922623 · Healthdyne, Inc. · Dec 1992
MAXI ASPIRATOR
K902184 · Medical Industries America, Inc. · Feb 1991
#504 MINI COMPRESSOR
K904045 · Medical Industries America, Inc. · Feb 1991
PM14 SOFT AIR COMPRESSOR
K902762 · Precision Medical, Inc. · Jul 1990