# K202919: ATS 5000 Automatic Tourniquet Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Mcewen and Associates Consulting, Ltd.
- Decided: May 20, 2021 after 233 days
- Product code: KCY (Tourniquet, Pneumatic)
- Device class: 1
- Regulation: 21 CFR 878.5910
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K840206 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123553: Zimmer a.T.S. 4000TS Automatic Tourniquet System, Zimmer, Inc. (2013) Summary page 4.

## Recalls of this device
- Dec 24, 2025 · Class II · Z-1201-2026: 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.

## Indications for use
The ATS 5000 Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient’s extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including: Reduction of certain fractures Kirschner wire removal Tumor and cyst excisions Subcutaneous fasciotomy Nerve injuries Tendon repair Bone grafts Total wrist joint replacement Replacement of joints in the fingers Knee joint replacements Amputations Replantations

Source page: https://510kreport.com/device/K202919
Methodology: https://510kreport.com/methodology