Cleared Traditional

K060781 - MEDICAL COMPRESSOR, MODELS DK50 D AND DM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
56d slower than avg
Panel avg: 139d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.