# K123553: Zimmer a.T.S. 4000TS Automatic Tourniquet System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Aug 9, 2013 after 263 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: 2 generations back to K840206 (1984). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050411: Zimmer a.T.S. 3000 Automatic Tourniquet System, Zimmer, Inc. (2005) Summary page 1.

## Most influential descendants
- K202919: ATS 5000 Automatic Tourniquet Instrument (2021), 0 descendants of its own

## Recalls of this device
- Jul 27, 2017 · Class II · Z-0612-2018: Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3.8 meters (m) to 1.0 separation distance between the device and RF communication equipment.

## Indications for use
The A. T.S. 4000TS 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 useflul 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 fatsciotomy, 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/K123553
Methodology: https://510kreport.com/methodology