Cleared Traditional

K060781 - MEDICAL COMPRESSOR, MODELS DK50 D AND DM

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 45
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K060781.
MEDICAL AIR COMPRESSOR
K113338 · Oricare, Inc. · Aug 2012
DK50 DS
K091871 · Ekom S.R.O. · Oct 2009
EMG TRITON -COMP,MODEL NCA01-XXX SERIES
K072634 · Emg Technology Co., Ltd. · Nov 2008
MINIMATE COMPRESSOR
K051691 · Precision Medical, Inc. · Dec 2005
VENTILAIR II MEDICAL AIR COMPRESSOR
K041781 · Hamilton Medical AG · Mar 2005
NEWPORT C250 AIR COMPRESSOR MODEL C250
K041406 · Newport Medical Instruments · Dec 2004