510(k) · Cleared
Recalled · Class II · 2025ATS 5000 Automatic Tourniquet Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mcewen and Associates Consulting, Ltd. · KCY Tourniquet, Pneumatic
Cleared on May 20, 2021 as substantially equivalent to K123553 (Zimmer, Inc., 2013) after a 233-day review. Its family tree reaches back 3 generations to 1984. It has been recalled once.
- Decided
- May 20, 2021
- Review
- 233 days
- Class
- Class I
- Product code
- KCY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K840206 (1984). No later device cites it as a predicate yet.
- Root · 3 generations backK840206 Pressure Sentry TourniquetRichards Medical Co., Inc. · 1984
- 2 generations backK050411 Zimmer a.T.S. 3000 Automatic Tourniquet SystemZimmer, Inc. · 2005 · Recalled
- 1 generation backK123553 Zimmer a.T.S. 4000TS Automatic Tourniquet SystemZimmer, Inc. · 2013 · Recalled
- This deviceK202919 ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K840206 | Pressure Sentry Tourniquet | Richards Medical Co., Inc. | 1984 | — |
| −2 | K050411 | Zimmer a.T.S. 3000 Automatic Tourniquet System | Zimmer, Inc. | 2005 | 1 |
| −1 | K123553 | Zimmer a.T.S. 4000TS Automatic Tourniquet System | Zimmer, Inc. | 2013 | 1 |
| 0 (this device) | K202919 | ATS 5000 Automatic Tourniquet Instrument | Mcewen and Associates Consulting, Ltd. | 2021 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K123553 | Zimmer a.T.S. 4000TS Automatic Tourniquet SystemSummary page 4…exemption classification. Predicate Device: Zimmer ® A.T.S. ® 4000 Automatic Tourniquet System, K123553, cleared 08/09/2013 Device Description: The ATS 5000 is a non-sterile dual-port microprocessor… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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-1201-2026 | 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?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All KCY devicesKCY Tourniquet, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202919: ATS 5000 Automatic Tourniquet Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202919
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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