Cleared Traditional

K202919 - ATS 5000 Automatic Tourniquet Instrument (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K202919 · Mcewen and Associates Consulting , Ltd. · General & Plastic Surgery device
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May 2021
Decision
233d
Days
Class 1
Risk

K202919 is an FDA 510(k) clearance for the ATS 5000 Automatic Tourniquet Instrument. Classified as Tourniquet, Pneumatic (product code KCY), Class I - General Controls.

Submitted by Mcewen and Associates Consulting , Ltd. (Vancouver, CA). The FDA issued a Cleared decision on May 20, 2021 after a review of 233 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5910 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K202919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2020
Decision Date May 20, 2021
Days to Decision 233 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 114d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KCY Tourniquet, Pneumatic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5910
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.