510(k) · Cleared
ClearedTourniquet Cuff; Pneumatic Tourniquet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Instruments Technology, Inc. · KCY Tourniquet, Pneumatic
Cleared on Oct 26, 2001 as substantially equivalent to K890014 (Instrumed, Inc., 1989) after a 74-day review. Its family tree reaches back 1 generation to 1989. 3 later devices descend from it.
- Decided
- Oct 26, 2001
- Review
- 74 days
- Class
- Class I
- Product code
- KCY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890014 (1989). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK890014 Disposable Color-CuffsInstrumed, Inc. · 1989
- This deviceK012632 Tourniquet Cuff; Pneumatic TourniquetMedical Instruments Technology, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK112384 Abdominal Tourniquet SystemCompression Works, LLC · 2011
- Descendant · 2 generations on · 1 of its ownK133029 Abdominal Aortic and Junctional Tourniquet (Aajt) DeviceCompression Works, LLC · 2013
- Descendant · 3 generations on · 0 of its ownK221661 Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Compression Works, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K112384Abdominal Tourniquet SystemCompression Works, LLC · 2011 · cites it directly2descendants
- K133029Abdominal Aortic and Junctional Tourniquet (Aajt) DeviceCompression Works, LLC · 2013 · 2 generations on1descendant
- K221661Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Compression Works, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890014 | Disposable Color-Cuffs | Instrumed, Inc. | 1989 | — |
| 0 (this device) | K012632 | Tourniquet Cuff; Pneumatic Tourniquet | Medical Instruments Technology, Inc. | 2001 | — |
| +1 | K112384 | Abdominal Tourniquet System | Compression Works, LLC | 2011 | — |
| +2 | K133029 | Abdominal Aortic and Junctional Tourniquet (Aajt) Device | Compression Works, LLC | 2013 | — |
| +3 | K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) | Compression Works, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K890014 | Disposable Color-CuffsSummary page 1…essible Classification: Class Il per 21 CFR 878.5910 HL. Predicate Device: MIT's reprocessed compressions cuffs are substantially equivalent to: Instrumed, Color Cuff (K890014) IV. Description of Device Tourniquet cuffs are composed of either a plastic or cloth cover, over one or more plastic or rubber… | 1989 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112384 | Abdominal Tourniquet System | 2011 | 2 |
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?
- Its one ancestor has no recall.
- Of its descendants, K112384 (Compression Works, LLC, 2011) has gone furthest, with 2 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.
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 intended use of a tourniquet cuff is to restrict blood flow to a patient’s limb during surgery.
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/K012632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012632: Tourniquet Cuff; Pneumatic Tourniquet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012632
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026