Cleared Traditional

K060781 - MEDICAL COMPRESSOR

K060781 is an FDA 510(k) clearance for MEDICAL COMPRESSOR, manufactured by Ekom S.R.O.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K060781 · Ekom S.R.O. · Anesthesiology device
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Oct 2006
Decision
195d
Days
Class 2
Risk

K060781 is an FDA 510(k) clearance for the MEDICAL COMPRESSOR, MODELS DK50 D AND DM. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Ekom S.R.O. (Dana Point, US). The FDA issued a Cleared decision on October 3, 2006 after a review of 195 days - an extended review 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: 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 Ekom S.R.O. devices

FDA 510(k) Submission Details - K060781

510(k) Number K060781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2006
Decision Date October 03, 2006
Days to Decision 195 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 140d · This submission: 195d
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 31
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K060781.
MINIMATE COMPRESSOR
K051691 · Precision Medical, Inc. · Dec 2005
VENTILAIR II MEDICAL AIR COMPRESSOR
K041781 · Hamilton Medical AG · Mar 2005
AEROMIST LT, MODEL HCS15004
K031686 · Medline Industries, Inc. · Jan 2004
COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
K023354 · Siemens Elema AB · Sep 2003
MEDICAL AIR COMPRESSOR, MODEL # 8413419
K982789 · Drager, Inc. · Oct 1998
DEVILBISS 8650D
K963349 · Devilbiss Health Care, Inc. · Jun 1997