510(k) Report

510(k) · Cleared

Cleared

Abdominal Aortic and Junctional Tourniquet (Aajt) Device

K133029510(k) TraditionalCleared Dec 6, 201371-day reviewClass II21 CFR 870.4450

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Compression Works, LLC · DXC Clamp, Vascular

Cleared on Dec 6, 2013 as substantially equivalent to K112384 (Compression Works, LLC, 2011) and 2 other predicates after a 71-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.

Decided
Dec 6, 2013
Review
71 days
Class
Class II
Product code
DXC
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K002767 (2000). 8 ancestors in all, the oldest K890014 (1989). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2011: 1 other ancestor2001: 1 other ancestor1989: 1 other ancestor2023: 1 descendant clearedK002767 · Compressar Femoral Access Compression Device · Semler Technologies, Inc. · 2000K102025 · Combat Ready Clamp · Combat Medical Systems, LLC · 2010×2: 2 generations cleared close together, K123694 (2013), K131561 (2013) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant K131561 · Sam Junctional Tourniquet · Sam Medical Products · 2013 · recalledK123694 · Sam Junctional Tourniquet · Sam Medical Products · 2013 · recalledK102025 · Combat Ready Clamp · Combat Medical Systems, LLC · 2010K002767 · Compressar Femoral Access Compression Device · Semler Technologies, Inc. · 20000
  1. Root · 4 generations backK002767 Compressar Femoral Access Compression DeviceSemler Technologies, Inc. · 2000
  2. 3 generations backK102025 Combat Ready ClampCombat Medical Systems, LLC · 2010
  3. 2 generations backK123694 Sam Junctional TourniquetSam Medical Products · 2013 · Recalled
  4. 1 generation backK131561 Sam Junctional TourniquetSam Medical Products · 2013 · Recalled
  5. This deviceK133029 Abdominal Aortic and Junctional Tourniquet (Aajt) DeviceCompression Works, LLC · 2013
  6. Descendant · cites it directly · 0 of its ownK221661 Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Compression Works, Inc. · 2023

Most influential descendants

Showing 1 of 1 · See all
  • K221661Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Compression Works, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K002767Compressar Femoral Access Compression DeviceSemler Technologies, Inc.2000—
−3K102025Combat Ready ClampCombat Medical Systems, LLC2010—
−2K123694Sam Junctional TourniquetSam Medical Products20131
−1K131561Sam Junctional TourniquetSam Medical Products20131
0 (this device)K133029Abdominal Aortic and Junctional Tourniquet (Aajt) DeviceCompression Works, LLC2013—
+1K221661Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Compression Works, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
200110
201110
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K133029, 2000–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K112384Abdominal Tourniquet System
Summary page 2
…fficult bleeds in the pelvis and axilla area) is substantially equivalent to the predicate AAT device cleared under K112384. It has equivalent design and materials, addresses the same patient population, has the same mechanism…
Compression Works, LLC2011—
*K130482Combat Ready Clamp
Summary page 1
…dominal Aortic Tourniquet (AAT) device (Ki 12384), the Combat Medical Systems, LLC's Combat Ready Clamp (CRoC) (K 130482) and the SAM Junctional Tourniquet (K 131I56 1). Device Classification This device, a vascular clamp carries an FDA pro…
Combat Medical Systems, LLC2013—
*K131561Sam Junctional TourniquetSam Medical Products20131

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K221661Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)Compression Works, Inc.20230

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 13 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K221661 (Compression Works, Inc., 2023) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DXC devices

DXC 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

2007: 102008: 32009: 42010: 22011: 62012: 52013: 142014: 42015: 52016: 32017: 32018: 22019: 22020: 32021: 62022: 12023: 42024: 12025: 22026 (partial year): 4
2007high 14 (2013) · low 1 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXC

215in 2023

2007: 52 days median2008: 29 days median2009: 83 days median2011: 51 days median2012: 73 days median2013: 89 days median2014: 157 days median2015: 71 days median2016: 91 days median2017: 90 days median2020: 209 days median2021: 37 days median2023: 215 days median2026 (partial year): 125 days median
2007high 215 (2023) · low 29 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXC

2in 2023

2008: 22009: 22010: 12011: 32014: 12022: 12023: 2
2007high 3 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXC

442in 2025

2007: 2982008: 3022009: 5392010: 6002011: 6912012: 5482013: 9202014: 4942015: 3742016: 4942017: 4162018: 3912019: 3932020: 4042021: 3712022: 2732023: 6742024: 3752025: 442
2007high 920 (2013) · low 273 (2022)2025

MAUDE reports naming product code DXC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200710520298
20083292302
20094832539
20102—1600
20116513691
20125730548
201314890920
201441571494
20155710374
20163910494
20173900416
20182—0391
20192—0393
202032090404
20216370371
20221—1273
202342152674
20241—0375
20252—0442
202641250—

What is it indicated for?

The Abdominal Aortic and Junctional Tourniquet is indicated for use in the battlefield to control difficult bleeds in the pelvis, inguinal area and axilla.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K133029: Abdominal Aortic and Junctional Tourniquet (Aajt) Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133029

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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