Cleared Special

K091871 - DK50 DS

K091871 is an FDA 510(k) clearance for DK50 DS, manufactured by Ekom S.R.O.. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Special 510(k) pathway after a 122-day FDA review.

K091871 · Ekom S.R.O. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
122d
Days
Class 2
Risk

K091871 is an FDA 510(k) clearance for the DK50 DS. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Ekom S.R.O. (Bonita Springs, US). The FDA issued a Cleared decision on October 23, 2009 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ekom S.R.O. devices

FDA 510(k) Submission Details - K091871

510(k) Number K091871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2009
Decision Date October 23, 2009
Days to Decision 122 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 140d · This submission: 122d
Pathway characteristics
Modification to existing cleared device.

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 K091871.
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