ATS 5000 Automatic Tourniquet Instrument— 510(k) K202919

Name: FDA 510(k) clearance K202919
Creator: U.S. Food and Drug Administration
Published: 2021-05-20

Substantially Equivalent

Mcewen and Associates Consulting , Ltd.

FDA 510(k) clearance K202919 for ATS 5000 Automatic Tourniquet Instrument, Substantially Equivalent on 2021-05-20. Applicant: Mcewen and Associates Consulting , Ltd.. Device class: 1.

Clearance details

Applicant: Mcewen and Associates Consulting , Ltd.
Product code: Code KCY
Device class: Class 1
Regulation: 21 CFR 878.5910
Advisory panel: General, Plastic Surgery
Date received: 2020-09-29
Decision date: 2021-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCY

view all

K162365 — T-Cuff2017-02-16
K123553 — ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM2013-08-09
K112874 — EZ VEIN INFLATABLE TOURNIQUET2011-10-17
K071140 — MRI COMPATIBLE THIGH TOURNIQUET, MODEL C0700022007-06-07
K050411 — ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM2005-09-02

Adverse events under product code KCY

product code KCY

Malfunction: 868
Total: 868

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K202919

K-number listed on FDA's recall record

Z-1201-2026 — Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/AClass II·Ongoing·Zimmer Surgical Inc·20251224

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202919.

Data sourced from openFDA. This site is unofficial and independent of the FDA.