510(k) · Cleared

Recalled · Class II · 2025

Junctional Emergency Treatment Tool Model 30-0088

K123194510(k) TraditionalCleared Jan 3, 201384-day reviewClass II21 CFR 870.4450Recalls 1

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

North American Rescue Products, Inc. · DXC Clamp, Vascular

Cleared on Jan 3, 2013 as substantially equivalent to K102025 (Combat Medical Systems, LLC, 2010) after an 84-day review. Its family tree reaches back 2 generations to 2000. It has been recalled once.

Decided: Jan 3, 2013
Review: 84 days
Class: Class II
Product code: DXC
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K002767 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002767 Compressar Femoral Access Compression DeviceSemler Technologies, Inc. · 2000
1 generation backK102025 Combat Ready ClampCombat Medical Systems, LLC · 2010
This deviceK123194 Junctional Emergency Treatment Tool Model 30-0088North American Rescue Products, Inc. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002767	Compressar Femoral Access Compression Device	Semler Technologies, Inc.	2000	—
−1	K102025	Combat Ready Clamp	Combat Medical Systems, LLC	2010	—
0 (this device)	K123194	Junctional Emergency Treatment Tool Model 30-0088	North American Rescue Products, Inc.	2013	—

FIG. 1 — Lineage of K123194, 2000–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K102025	Combat Ready Clamp Summary page 1 …Common Name iVascular Clamp Code -Name -Classification DXC - Vascular Clamp 21 CFR 870,4450: Class It Predicate Devices tCombat Ready Clamp K1 02025 Device Description Device Description: The Junctional Emergency Treatment Tool is designed to be…	Combat Medical Systems, LLC	2010	—

Also cleared against K102025: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 1, 2025	Class II	Z-2637-2025	Nonconforming Material/Component	Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.

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 9.9 years on median.
None of the 2 ancestors has a recall.
4 other devices also cite its predicate K102025.

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

2007high 14 (2013) · low 1 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXC

215in 2023

2007high 215 (2023) · low 29 (2008)2026

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

Recalls per year · DXC

2in 2023

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

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

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 North American Rescue Junctional Emergency Treatment Tool is indicated for emergent purposes to control difficult bleeds in the inguinal area.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123194 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123194: Junctional Emergency Treatment Tool Model 30-0088.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123194

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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