510(k) · Cleared

Cleared

Instrumed Vascular Clamps

K092544510(k) TraditionalCleared Oct 26, 200968-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

Instrumed International, Inc. · DXC Clamp, Vascular

Cleared on Oct 26, 2009 as substantially equivalent to K072834 (Surgical Instruments Belgium SA, 2008) and 5 other predicates after a 68-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.

Decided: Oct 26, 2009
Review: 68 days
Class: Class II
Product code: DXC
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K022754 (2002). 6 ancestors in all, the oldest K973080 (1998). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK022754 S&T Single Use Micro Anastomosis ClampS & T AG · 2002
1 generation backK070661 Vitalcor Featherweight Vascular ClampsVitalcor, Inc. · 2007
This deviceK092544 Instrumed Vascular ClampsInstrumed International, Inc. · 2009
Descendant · cites it directly · 0 of its ownK120492 K2 Medical Vascular ClampsK2 Medical GmbH & Co. KG · 2012

Most influential descendants

Showing 1 of 1 · See all

K120492K2 Medical Vascular ClampsK2 Medical GmbH & Co. KG · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K022754	S&T Single Use Micro Anastomosis Clamp	S & T AG	2002	—
−1	K070661	Vitalcor Featherweight Vascular Clamps	Vitalcor, Inc.	2007	—
0 (this device)	K092544	Instrumed Vascular Clamps	Instrumed International, Inc.	2009	—
+1	K120492	K2 Medical Vascular Clamps	K2 Medical GmbH & Co. KG	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2000	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K092544, 2002–2012Source: 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

Get a 510(k) Report

What was it cleared against? (11)

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
*	K072834	Sibel SA Vascular Clamp Summary page 1 …asive Coronary Systems Classification name: Clamp, Vascular (21 CFR 870.4450, Product code DXC) Regulation Description Vascular Clamp Substantial Equivalence Claims: K072834 SIBEL SA VASCULAR CLAMP; SURGICAL INSTRUMENTS BELGIUM SA P.D. K973080 Surgical Vascular Clamp, Waiter Loren…	Surgical Instruments Belgium SA	2008	—
*	K973080	Surgical Vascular Clamp Summary page 1 …DXC) Regulation Description Vascular Clamp Substantial Equivalence Claims: K072834 SIBEL SA VASCULAR CLAMP; SURGICAL INSTRUMENTS BELGIUM SA P.D. K973080 Surgical Vascular Clamp, Waiter Lorenz Surgical, Inc K992053 AESCULAP VASCULAR INSTRUMENTS AESCULAP, INC.…	Walter Lorenz Surgical, Inc.	1998	—
*	K992053	Aesculap Vascular Instruments Summary page 1 …ivalence Claims: K072834 SIBEL SA VASCULAR CLAMP; SURGICAL INSTRUMENTS BELGIUM SA P.D. K973080 Surgical Vascular Clamp, Waiter Lorenz Surgical, Inc K992053 AESCULAP VASCULAR INSTRUMENTS AESCULAP, INC. P.D. Preamnendments: Aesculap, Codman, Heartport,…	Aesculap, Inc.	2000	—
*	K070661	Vitalcor Featherweight Vascular Clamps Summary page 1 …l, Inc K992053 AESCULAP VASCULAR INSTRUMENTS AESCULAP, INC. P.D. Preamnendments: Aesculap, Codman, Heartport, V.Mueller, Walter Lorenz K070661 VITALCOR FEATHERWEIGHT VASCULAR CLAMPS; VITALCOR, INC. P.D. K022754 S&T SINGLE USE MICRO ANASTOMOSIS CLAMP;…	Vitalcor, Inc.	2007	—
*	K022754	S&T Single Use Micro Anastomosis Clamp Summary page 1 …P.D. Preamnendments: Aesculap, Codman, Heartport, V.Mueller, Walter Lorenz K070661 VITALCOR FEATHERWEIGHT VASCULAR CLAMPS; VITALCOR, INC. P.D. K022754 S&T SINGLE USE MICRO ANASTOMOSIS CLAMP; S &TAG K982278 MICRINS MICRO ANASTOMOSIS CLAMP; MICRINS SURGICAL, INC. === Page 2…	S & T AG	2002	—
*	K982278	Micrins Micro Anastomosis Clamp Summary page 1 ….Mueller, Walter Lorenz K070661 VITALCOR FEATHERWEIGHT VASCULAR CLAMPS; VITALCOR, INC. P.D. K022754 S&T SINGLE USE MICRO ANASTOMOSIS CLAMP; S &TAG K982278 MICRINS MICRO ANASTOMOSIS CLAMP; MICRINS SURGICAL, INC.…	Micrins Surgical, Inc.	1999	—
*	—	Aesculap Named without a submission number			—
*	—	Codman Named without a submission number			—
*	—	Heartport Named without a submission number			—
*	—	V.Mueller Named without a submission number			—
*	—	Walter Lorenz Named without a submission number			—

Also cleared against K072834: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K120492	K2 Medical Vascular Clamps	K2 Medical GmbH & Co. KG	2012	0

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 7 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K120492 (K2 Medical GmbH & Co. KG, 2012) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K072834.

How does its category compare?

All DXC devices

DXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?

INSTRUMED Vascular Clamps are devices intended for temporary or partial occlusion of blood vessels during vascular surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092544 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092544: Instrumed Vascular Clamps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092544

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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