510(k) · Cleared

Cleared

Cstat, Models 09-0014-01 and 09-0014-02

K032125510(k) TraditionalCleared Feb 9, 2004214-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

Vascular Control Systems, Inc. · DXC Clamp, Vascular

Cleared on Feb 9, 2004 as substantially equivalent to K023154 (Vascular Control Systems, Inc., 2002) and 2 other predicates after a 214-day review. Its family tree reaches back 3 generations to 1995.

Decided: Feb 9, 2004
Review: 214 days
Class: Class II
Product code: DXC
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K935994 (1995). 7 ancestors in all, the oldest K862160 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK935994 PW Doppler Vascular ProbesKoven Technology, Inc. · 1995
2 generations backK011863 VCS-a Series ClampVascular Control Systems, Inc. · 2002
1 generation backK023154 VCS-a Series Clamp with Doppler Ultrasound, Model 09-0007-01 and…Vascular Control Systems, Inc. · 2002
This deviceK032125 Cstat, Models 09-0014-01 and 09-0014-02Vascular Control Systems, Inc. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K935994	PW Doppler Vascular Probes	Koven Technology, Inc.	1995	—
−2	K011863	VCS-a Series Clamp	Vascular Control Systems, Inc.	2002	—
−1	K023154	VCS-a Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02	Vascular Control Systems, Inc.	2002	—
0 (this device)	K032125	Cstat, Models 09-0014-01 and 09-0014-02	Vascular Control Systems, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1998	1	0
2002	2	0

FIG. 1 — Lineage of K032125, 1995–2004Source: 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K023154	VCS-a Series Clamp with Doppler Ultrasound, Model 09-0007-01 and 09-0007-02 Summary page 1 …ng claimed: Company: Vascular Control Systems, Inc. Device: VCS-A Clamp 510(k): K023154 Date Cleared: December 20, 2002 Company: Vascular Control Systems, Inc.…	Vascular Control Systems, Inc.	2002	—
*	K023024	Transvaginal Doppler Probe, Model 09-0006-02 Summary page 1 …Company: Vascular Control Systems, Inc. Device: Transvaginal Doppler Probe 510(k): K023024 Date Cleared: September 26, 2002 Company: Medical Designs LLC…	Vascular Control Systems, Inc.	2002	—
*	K022712	Hand Drill, Model 11-9901-7 Summary page 1 …September 26, 2002 Company: Medical Designs LLC Device: Hand Drill 510(k): K022712 Date Cleared: November 12, 2002…	Medical Design, LLC	2002	—

What descends from it?

No later submission names this one as a predicate yet.

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 9 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
None of the 7 ancestors has a recall.

How does its category compare?

All DXC devices

DXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Cstat is intended for detection and temporary occlusion of blood vessels during vascular surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032125 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032125: Cstat, Models 09-0014-01 and 09-0014-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032125

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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