Cleared Traditional

K202919 - ATS 5000 Automatic Tourniquet Instrument

K202919 is an FDA 510(k) clearance for ATS 5000 Automatic Tourniquet Instrument, manufactured by Mcewen and Associates Consulting , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code KCY cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K202919 · Mcewen and Associates Consulting , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Mcewen and Associates Consulting , Ltd. devices

FDA 510(k) Submission Details - K202919

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
118d slower than avg
Panel avg: 115d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

KCY Device Classification - Class 1, General Controls

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.

Regulatory Peers - KCY Tourniquet, Pneumatic

All 14
Devices cleared under the same product code (KCY) and FDA review panel - the closest regulatory comparables to K202919.
ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM
K123553 · Zimmer, Inc. · Aug 2013
ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM
K050411 · Zimmer, Inc. · Sep 2005
EXPRESSAIRE TORUNIQUET SYSTEM
K955552 · Smith & Nephew Richards, Inc. · Jan 1996
DEROYAL INDUSTRIES, INC. PNEUMATIC TOURNIQUET CUFF
K953953 · Deroyal Industries, Inc. · Sep 1995
ARTHREX TOURNIQUET FOR LEG HOLDER
K933994 · Arthrex, Inc. · Mar 1994
STILLE AUTOMATIC TOURNIQUET
K925033 · Ferguson Medical · Feb 1993