Cleared Traditional

K850795 - AIR COMPRESSOR

K850795 is an FDA 510(k) clearance for AIR COMPRESSOR, manufactured by Bear Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K850795 · Bear Medical Systems, Inc. · Anesthesiology device
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May 1985
Decision
110d
Days
Class 2
Risk

K850795 is an FDA 510(k) clearance for the AIR COMPRESSOR. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Bear Medical Systems, Inc. (Lancaster, US). The FDA issued a Cleared decision on May 28, 1985 after a review of 110 days - within the typical 510(k) review window.

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 Bear Medical Systems, Inc. devices

FDA 510(k) Submission Details - K850795

510(k) Number K850795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1985
Decision Date May 28, 1985
Days to Decision 110 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
30d faster than avg
Panel avg: 140d · This submission: 110d
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 K850795.
BIRD 6500 AIR COMPRESSOR
K864547 · Bird Products Corp. · Jan 1987
BUNN MODEL 510 MEDICATION COMPRESSOR
K862628 · The John Bunn Co. · Aug 1986
OHMEDA CPU AIR COMPRESSOR MODEL 3350
K854306 · Ohmeda Medical · Nov 1985
IMPACT MODEL 601
K841537 · Impact Instrumentation, Inc. · May 1984
MEDI-MIST PORTA. COMPRESSOR DRIVEN
K833501 · Mountain Medical Equipment, Inc. · Dec 1983
PCS-5 ACCESSORIES
K812766 · Timeter Instrument Corp. · Dec 1981