Cleared Traditional

K902762 - PM14 SOFT AIR COMPRESSOR

K902762 is an FDA 510(k) clearance for PM14 SOFT AIR COMPRESSOR, manufactured by Precision Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K902762 · Precision Medical, Inc. · Anesthesiology device
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Jul 1990
Decision
35d
Days
Class 2
Risk

K902762 is an FDA 510(k) clearance for the PM14 SOFT AIR COMPRESSOR. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on July 30, 1990 after a review of 35 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.

View all Precision Medical, Inc. devices

FDA 510(k) Submission Details - K902762

510(k) Number K902762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1990
Decision Date July 30, 1990
Days to Decision 35 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
105d faster than avg
Panel avg: 140d · This submission: 35d
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 19
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K902762.
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
SIEMENS DRY AIR COMPRESSOR
K871829 · Siemens Elema AB · Jun 1987
BIRD 6500 AIR COMPRESSOR
K864547 · Bird Products Corp. · Jan 1987
OHMEDA CPU AIR COMPRESSOR MODEL 3350
K854306 · Ohmeda Medical · Nov 1985