510(k) · Cleared
Recalled · Class II · 2025Zimmer a.T.S. 3000 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 Sep 2, 2005 as substantially equivalent to K840206 (Richards Medical Co., Inc., 1984) after a 197-day review. Its family tree reaches back 1 generation to 1984. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 2, 2005
- Review
- 197 days
- Class
- Class I
- Product code
- KCY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K840206 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK840206 Pressure Sentry TourniquetRichards Medical Co., Inc. · 1984
- This deviceK050411 Zimmer a.T.S. 3000 Automatic Tourniquet SystemZimmer, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK123553 Zimmer a.T.S. 4000TS Automatic Tourniquet SystemZimmer, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK202919 ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting, Ltd. · 2021 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K840206 | Pressure Sentry Tourniquet | Richards Medical Co., Inc. | 1984 | — |
| 0 (this device) | K050411 | Zimmer a.T.S. 3000 Automatic Tourniquet System | Zimmer, Inc. | 2005 | — |
| +1 | K123553 | Zimmer a.T.S. 4000TS Automatic Tourniquet System | Zimmer, Inc. | 2013 | 1 |
| +2 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K840206 | Pressure Sentry TourniquetSummary page 1…21 CFR § 878.5910 Predicate Devices: Richards Pressure Sentry Tourniquet, manufactured by Richards Medical, K840206, cleared April 25, 1984. Zimmer A. TS. 2000 Tourniquet S… | 1984 |
| * | — | Zimmer A.T.S. 2000 Tourniquet System Named without a submission number | |
| * | — | Medasonics Versatone D9 stethoscope Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123553 | Zimmer a.T.S. 4000TS Automatic Tourniquet System | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 24, 2025 | Class II | Z-1202-2026 | Under Investigation by firm | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K123553 (Zimmer, Inc., 2013) has gone furthest, with 1 descendant 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.
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. 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050411: Zimmer a.T.S. 3000 Automatic Tourniquet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050411
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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