510(k) · Cleared
ClearedT-Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumobct, Inc. · KCY Tourniquet, Pneumatic
Cleared on Feb 16, 2017 as substantially equivalent to K112874 (Dominion Medical Devices, LLC, 2011) after a 177-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Feb 16, 2017
- Review
- 177 days
- Class
- Class I
- Product code
- KCY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K875092 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K875092 | Degania Silicone Tourniquet | Degania Silicone, Ltd. | 1988 | — |
| −1 | K112874 | EZ Vein Inflatable Tourniquet | Dominion Medical Devices, LLC | 2011 | — |
| 0 (this device) | K162365 | T-Cuff | Terumobct, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 |
|---|---|---|---|
| * | K112874 | EZ Vein Inflatable TourniquetSummary page 4…Dominion Medical Predicate KCY K112874 tourniquet Devices, LLC IV. DEVICE DESC… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 23.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All KCY devicesKCY Tourniquet, Pneumatic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
T-Cuff is indicated for use in donor populations during apheresis procedures as an alternative method to maintain pressure on the arm and obtain venipuncture. The T-Cuff operates similar to a pneumatic tourniquet intended to partially restrict blood flow on the upper arm to result in optimal venous access during apheresis collection procedures.
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/K162365 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162365: T-Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162365
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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