510(k) · Cleared
ClearedAbdominal Tourniquet System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Compression Works, LLC · DXC Clamp, Vascular
Cleared on Oct 18, 2011 as substantially equivalent to K102025 (Combat Medical Systems, LLC, 2010) and 1 other predicate after a 61-day review. Its family tree reaches back 2 generations to 1989. 2 later devices descend from it.
- Decided
- Oct 18, 2011
- Review
- 61 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K890014 (1989). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK890014 Disposable Color-CuffsInstrumed, Inc. · 1989
- 1 generation backK012632 Tourniquet Cuff; Pneumatic TourniquetMedical Instruments Technology, Inc. · 2001
- This deviceK112384 Abdominal Tourniquet SystemCompression Works, LLC · 2011
- Descendant · cites it directly · 1 of its ownK133029 Abdominal Aortic and Junctional Tourniquet (Aajt) DeviceCompression Works, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK221661 Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Compression Works, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −2 | K890014 | Disposable Color-Cuffs | Instrumed, Inc. | 1989 | — |
| −1 | K012632 | Tourniquet Cuff; Pneumatic Tourniquet | Medical Instruments Technology, Inc. | 2001 | — |
| 0 (this device) | K112384 | Abdominal Tourniquet System | Compression Works, LLC | 2011 | — |
| +1 | K133029 | Abdominal Aortic and Junctional Tourniquet (Aajt) Device | Compression Works, LLC | 2013 | — |
| +2 | K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) | Compression Works, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DXC? 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 DXC device
- #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K102025 | Combat Ready ClampSummary page 1…(AAT) Substantial The Abdominal Aortic Tourniquet is substantially equivalent to: Equivalence Combat Medical System's Combat Ready Clamp (K 102025) and the Zimmer A.T. S. Automatic Pneumatic Tourniquet System (KO 12632). Device This devic… | 2010 |
| * | K012632 | Tourniquet Cuff; Pneumatic Tourniquet | 2001 |
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 |
|---|---|---|---|
| K133029 | Abdominal Aortic and Junctional Tourniquet (Aajt) Device | 2013 | 1 |
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 22 years and passes through 3 companies; a new generation was cleared every 12.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K133029 (Compression Works, LLC, 2013) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K102025.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DXC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXC
215in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXC
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXC
442in 2025
MAUDE reports naming product code DXC, 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 | 10 | 52 | 0 | 298 |
| 2008 | 3 | 29 | 2 | 302 |
| 2009 | 4 | 83 | 2 | 539 |
| 2010 | 2 | — | 1 | 600 |
| 2011 | 6 | 51 | 3 | 691 |
| 2012 | 5 | 73 | 0 | 548 |
| 2013 | 14 | 89 | 0 | 920 |
| 2014 | 4 | 157 | 1 | 494 |
| 2015 | 5 | 71 | 0 | 374 |
| 2016 | 3 | 91 | 0 | 494 |
| 2017 | 3 | 90 | 0 | 416 |
| 2018 | 2 | — | 0 | 391 |
| 2019 | 2 | — | 0 | 393 |
| 2020 | 3 | 209 | 0 | 404 |
| 2021 | 6 | 37 | 0 | 371 |
| 2022 | 1 | — | 1 | 273 |
| 2023 | 4 | 215 | 2 | 674 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 2 | — | 0 | 442 |
| 2026 | 4 | 125 | 0 | — |
What is it indicated for?
The Abdomninal Aortic Tourniquet is indicated for use in the battlefield to control difficult bleeds in the inguinal area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112384 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112384: Abdominal Tourniquet System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112384
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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