Cleared Traditional

K863339 - DURA NEB(TM) 2000 PORTABLE COMPRESSOR

K863339 is an FDA 510(k) clearance for DURA NEB(TM) 2000 PORTABLE COMPRESSOR, manufactured by Thera Tec, Inc.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K863339 · Thera Tec, Inc. · Anesthesiology device
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Oct 1986
Decision
40d
Days
Class 2
Risk

K863339 is an FDA 510(k) clearance for the DURA NEB(TM) 2000 PORTABLE COMPRESSOR. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Thera Tec, Inc. (Treasure Island, US). The FDA issued a Cleared decision on October 7, 1986 after a review of 40 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 - K863339

510(k) Number K863339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1986
Decision Date October 07, 1986
Days to Decision 40 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 140d · This submission: 40d
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 K863339.
ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER
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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
AIR COMPRESSOR
K850795 · Bear Medical Systems, Inc. · May 1985
K863339 · DURA NEB(TM) 2000 PORTABLE COMPRESSOR
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