510(k) Report

510(k) · Cleared

Cleared

Combat Ready Clamp

K102025510(k) TraditionalCleared Aug 11, 201023-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

Combat Medical Systems, LLC · DXC Clamp, Vascular

Cleared on Aug 11, 2010 as substantially equivalent to K002767 (Semler Technologies, Inc., 2000) after a 23-day review. Its family tree reaches back 1 generation to 2000. 11 later devices descend from it.

Decided
Aug 11, 2010
Review
23 days
Class
Class II
Product code
DXC
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002767 (2000). 11 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2013: 6 descendants cleared2011: 1 descendant cleared2015: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant clearedK002767 · Compressar Femoral Access Compression Device · Semler Technologies, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 3 descendants3 generations forward: 3 descendants K002767 · Compressar Femoral Access Compression Device · Semler Technologies, Inc. · 20000
  1. Root · 1 generation backK002767 Compressar Femoral Access Compression DeviceSemler Technologies, Inc. · 2000
  2. This deviceK102025 Combat Ready ClampCombat Medical Systems, LLC · 2010
  3. Descendant · cites it directly · 4 of its ownK130482 Combat Ready ClampCombat Medical Systems, LLC · 2013
  4. Descendant · cites it directly · 4 of its ownK123694 Sam Junctional TourniquetSam Medical Products · 2013 · Recalled
  5. Descendant · 2 generations on · 3 of its ownK131561 Sam Junctional TourniquetSam Medical Products · 2013 · Recalled
  6. Descendant · cites it directly · 2 of its ownK112384 Abdominal Tourniquet SystemCompression Works, LLC · 2011
  7. Descendant · 2 generations on · 1 of its ownK141685 CROCCombat Medical Systems, LLC · 2015

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2011: 12013: 62015: 12023: 12025: 12026: 1
2011high 6 (2013) · low 0 (2012)2026

Most influential descendants

Showing 5 of 11 · See all
  • K130482Combat Ready ClampCombat Medical Systems, LLC · 2013 · cites it directly4descendants
  • K123694Sam Junctional TourniquetSam Medical Products · 2013 · cites it directly4descendants
  • K131561Sam Junctional TourniquetSam Medical Products · 2013 · 2 generations on3descendants
  • K112384Abdominal Tourniquet SystemCompression Works, LLC · 2011 · cites it directly2descendants
  • K141685CROCCombat Medical Systems, LLC · 2015 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002767Compressar Femoral Access Compression DeviceSemler Technologies, Inc.2000—
0 (this device)K102025Combat Ready ClampCombat Medical Systems, LLC2010—
+1K130482Combat Ready ClampCombat Medical Systems, LLC2013—
+1K123694Sam Junctional TourniquetSam Medical Products20131
+2K131561Sam Junctional TourniquetSam Medical Products20131
+1K112384Abdominal Tourniquet SystemCompression Works, LLC2011—
+2K141685CROCCombat Medical Systems, LLC2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201360
201510
202310
202510
202610
FIG. 1 — Lineage of K102025, 2000–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K002767Compressar Femoral Access Compression Device
Summary page 1
…tion: 21 CFR 870.4450, Class 11, 5 10O(k) Panel: Cardiovascular Product Code: DXC Predicates: K002767 Compressar Femoral Access Compression Device Indication for Use: The Combat Ready Clamp is indicated for use in the battlefield…
Semler Technologies, Inc.2000—

Also cleared against K002767: 1 other device →

What descends from it? (11)

See all 11

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130482Combat Ready ClampCombat Medical Systems, LLC20134
K123694Sam Junctional TourniquetSam Medical Products20134
K112384Abdominal Tourniquet SystemCompression Works, LLC20112
K123551Itclamp 50Innovative Trauma Care, Inc.20130
K123194Junctional Emergency Treatment Tool Model 30-0088North American Rescue Products, Inc.20130

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, K130482 (Combat Medical Systems, LLC, 2013) has gone furthest, with 4 descendants of its own.
  • 1 other device also cites its predicate K002767.

How does its category compare?

All DXC devices

DXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Combat Ready Clamp is indicated for use in the battlefield to control difficult bleeds in the inguinal area.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K102025: Combat Ready Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102025

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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