Cleared Traditional

K800534 - MODEL 52 BUNN DRY AIR SUPPLY

K800534 is an FDA 510(k) clearance for MODEL 52 BUNN DRY AIR SUPPLY, manufactured by Greene & Kellogg, Inc.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K800534 · Greene & Kellogg, Inc. · Anesthesiology device
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Mar 1980
Decision
18d
Days
Class 2
Risk

K800534 is an FDA 510(k) clearance for the MODEL 52 BUNN DRY AIR SUPPLY. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Greene & Kellogg, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1980 after a review of 18 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K800534

510(k) Number K800534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1980
Decision Date March 25, 1980
Days to Decision 18 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 140d · This submission: 18d
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 52
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K800534.
PCS-5 ACCESSORIES
K812766 · Timeter Instrument Corp. · Dec 1981
SNIFF AIR COMPRESSOR #SF-6
K812767 · Timeter Instrument Corp. · Nov 1981
AIR COMPRESSOR ADAPTOR KIT
K802253 · Hudson Oxygen Therapy Sales Co. · Sep 1980
COMPRESSOR
K792457 · Pneupac , Ltd. · Feb 1980
ARIDYNE 3500
K790912 · Timeter Instrument Corp. · May 1979
COMPRESSOR, AIR, MINI-SILENT
K781213 · The John Bunn Co. · Jul 1978
K800534 · MODEL 52 BUNN DRY AIR SUPPLY
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