# K050411: Zimmer a.T.S. 3000 Automatic Tourniquet System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Sep 2, 2005 after 197 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: 1 generation back to K840206 (1984). 1 ancestor in all.
2 later devices descend 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)
- K840206: Pressure Sentry Tourniquet, Richards Medical Co., Inc. (1984) Summary page 1.
- (no number) Zimmer A.T.S. 2000 Tourniquet System: named in the summary without a submission number
- (no number) Medasonics Versatone D9 stethoscope: named in the summary without a submission number

## Most influential descendants
- K123553: Zimmer a.T.S. 4000TS Automatic Tourniquet System (2013), 1 descendant of its own
- K202919: ATS 5000 Automatic Tourniquet Instrument (2021), 0 descendants of its own

## Recalls of this device
- Dec 24, 2025 · Class II · Z-1202-2026: 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 A. T.S. 3000 Automatic 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/K050411
Methodology: https://510kreport.com/methodology