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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 45
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K091871.
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