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ATS 5000 Automatic Tourniquet Instrument

by Mcewen and Associates Consulting, Ltd.

510(k) K202919

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK202919 Date20 May 2021ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1201-2026 FDA Class II initiated 24 Dec 2025

    Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KCY
FDA applicant
Mcewen and Associates Consulting , Ltd.
Device Class
Class I
Regulation
21 CFR Part 878.5910
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent