510(k) · Cleared
Recalled · Class II · 2017Zimmer a.T.S. 4000TS Automatic Tourniquet System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · KCY Tourniquet, Pneumatic
Cleared on Aug 9, 2013 as substantially equivalent to K050411 (Zimmer, Inc., 2005) after a 263-day review. Its family tree reaches back 2 generations to 1984. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 9, 2013
- Review
- 263 days
- Class
- Class I
- Product code
- KCY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K840206 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK840206 Pressure Sentry TourniquetRichards Medical Co., Inc. · 1984
- 1 generation backK050411 Zimmer a.T.S. 3000 Automatic Tourniquet SystemZimmer, Inc. · 2005 · Recalled
- This deviceK123553 Zimmer a.T.S. 4000TS Automatic Tourniquet SystemZimmer, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK202919 ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting, Ltd. · 2021 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K202919ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K840206 | Pressure Sentry Tourniquet | Richards Medical Co., Inc. | 1984 | — |
| −1 | K050411 | Zimmer a.T.S. 3000 Automatic Tourniquet System | Zimmer, Inc. | 2005 | 1 |
| 0 (this device) | K123553 | Zimmer a.T.S. 4000TS Automatic Tourniquet System | Zimmer, Inc. | 2013 | — |
| +1 | K202919 | ATS 5000 Automatic Tourniquet Instrument | Mcewen and Associates Consulting, Ltd. | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KCY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KCY device
- #1 K202919 ATS 5000 Automatic Tourniquet Instrumentscore -0.0 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050411 | Zimmer a.T.S. 3000 Automatic Tourniquet SystemSummary page 1…8.59 10 - Pneumatic tourniquet Predicate Device: Zimmer®A. T.S.® 3000 Automatic Tourniquet System, K05041 1, cleared 09/02/2005 Device Description: The Zimmer A. 7'S. 4000TS Tourniquet System is a… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202919 | ATS 5000 Automatic Tourniquet Instrument | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2017 | Class II | Z-0612-2018 | Use error | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 21.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K202919 (Mcewen and Associates Consulting, Ltd., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KCY devicesKCY Tourniquet, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · KCY
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KCY
Too few KCY 510(k)s in any year since 2007 to give a median.
Recalls per year · KCY
67so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCY
118in 2025
MAUDE reports naming product code KCY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 19 |
| 2008 | 0 | — | 7 | 33 |
| 2009 | 0 | — | 0 | 46 |
| 2010 | 0 | — | 3 | 47 |
| 2011 | 1 | — | 1 | 61 |
| 2012 | 0 | — | 1 | 67 |
| 2013 | 1 | — | 1 | 55 |
| 2014 | 0 | — | 0 | 63 |
| 2015 | 0 | — | 2 | 43 |
| 2016 | 0 | — | 1 | 72 |
| 2017 | 1 | — | 2 | 110 |
| 2018 | 0 | — | 0 | 145 |
| 2019 | 0 | — | 2 | 129 |
| 2020 | 0 | — | 0 | 119 |
| 2021 | 1 | — | 0 | 130 |
| 2022 | 0 | — | 1 | 90 |
| 2023 | 0 | — | 0 | 347 |
| 2024 | 0 | — | 0 | 107 |
| 2025 | 0 | — | 0 | 118 |
| 2026 | 0 | — | 67 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123553 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123553: Zimmer a.T.S. 4000TS Automatic Tourniquet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123553
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026