Cleared Traditional

K982789 - MEDICAL AIR COMPRESSOR

K982789 is an FDA 510(k) clearance for MEDICAL AIR COMPRESSOR, manufactured by Drager, Inc.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K982789 · Drager, Inc. · Anesthesiology device
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Oct 1998
Decision
80d
Days
Class 2
Risk

K982789 is an FDA 510(k) clearance for the MEDICAL AIR COMPRESSOR, MODEL # 8413419. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Drager, Inc. (Telford, US). The FDA issued a Cleared decision on October 29, 1998 after a review of 80 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 Drager, Inc. devices

FDA 510(k) Submission Details - K982789

510(k) Number K982789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1998
Decision Date October 29, 1998
Days to Decision 80 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 140d · This submission: 80d
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 25
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K982789.
VENTILAIR II MEDICAL AIR COMPRESSOR
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AEROMIST LT, MODEL HCS15004
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K023354 · Siemens Elema AB · Sep 2003
DEVILBISS 8650D
K963349 · Devilbiss Health Care, Inc. · Jun 1997
PM PUMP COMPRESSOR
K930509 · Precision Medical, Inc. · Oct 1994
DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER
K931015 · Devilbiss Health Care, Inc. · Sep 1993