510(k) · Cleared
Recalled · Class II · 2014Sam Junctional Tourniquet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sam Medical Products · DXC Clamp, Vascular
Cleared on Jul 24, 2013 as substantially equivalent to K123694 (Sam Medical Products, 2013) after a 55-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 24, 2013
- Review
- 55 days
- Class
- Class II
- Product code
- DXC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002767 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK002767 Compressar Femoral Access Compression DeviceSemler Technologies, Inc. · 2000
- 2 generations backK102025 Combat Ready ClampCombat Medical Systems, LLC · 2010
- 1 generation backK123694 Sam Junctional TourniquetSam Medical Products · 2013 · Recalled
- This deviceK131561 Sam Junctional TourniquetSam Medical Products · 2013
- Descendant · cites it directly · 1 of its ownK133029 Abdominal Aortic and Junctional Tourniquet (Aajt) DeviceCompression Works, LLC · 2013
- Descendant · cites it directly · 0 of its ownK254060 Life Saving TourniquetTW Medical · 2026
- Descendant · 2 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- K133029Abdominal Aortic and Junctional Tourniquet (Aajt) DeviceCompression Works, LLC · 2013 · cites it directly1descendant
- K254060Life Saving TourniquetTW Medical · 2026 · cites it directly0descendants
- K221661Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Compression Works, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002767 | Compressar Femoral Access Compression Device | Semler Technologies, Inc. | 2000 | — |
| −2 | K102025 | Combat Ready Clamp | Combat Medical Systems, LLC | 2010 | — |
| −1 | K123694 | Sam Junctional Tourniquet | Sam Medical Products | 2013 | 1 |
| 0 (this device) | K131561 | Sam Junctional Tourniquet | Sam Medical Products | 2013 | — |
| +1 | K133029 | Abdominal Aortic and Junctional Tourniquet (Aajt) Device | Compression Works, LLC | 2013 | — |
| +1 | K254060 | Life Saving Tourniquet | TW Medical | 2026 | — |
| +2 | 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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K123694 | Sam Junctional TourniquetSummary page 2…manufactured by: SAM Junctional Tourniquet (SJT), SAM Medical Products SJT Attribute: New Submission: Cleared (K123694) Target Population: Trauma Yes Yes Patients 2 Indicated fo… | 2013 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 14, 2014 | Class II | Z-0133-2015 | Component design/selection | SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap hook on auxiliary strap broke during training demonstration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K133029 (Compression Works, LLC, 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 SAM Junctional Tourniquet is indicated for battlefield and trauma situations:
To control difficult bleeds in the inguinal area.
To control difficult bleeds in the axilla area.
To immobilize a pelvic fracture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131561 · printed Nov 4, 2026
Cite this page
510(k) Report. “K131561: Sam Junctional Tourniquet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K131561
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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