510(k) · Cleared

Cleared

Microfrance (R) Wormald Vascular Clamp

K112662510(k) TraditionalCleared Jan 20, 2012129-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

Medtronic Xomed, Inc. · DXC Clamp, Vascular

Cleared on Jan 20, 2012 as substantially equivalent to K110148 (Microsurgical Laboratories,Inc.Dba Wexler Surgical, 2011) after a 129-day review. Its family tree reaches back 3 generations to 1998.

Decided: Jan 20, 2012
Review: 129 days
Class: Class II
Product code: DXC
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K973080 (1998). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK973080 Surgical Vascular ClampWalter Lorenz Surgical, Inc. · 1998
2 generations backK072834 Sibel SA Vascular ClampSurgical Instruments Belgium SA · 2008
1 generation backK110148 Wexler Vascular Clamp SeriesMicrosurgical Laboratories,Inc.Dba Wexler Surgical · 2011
This deviceK112662 Microfrance (R) Wormald Vascular ClampMedtronic Xomed, Inc. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K973080	Surgical Vascular Clamp	Walter Lorenz Surgical, Inc.	1998	—
−2	K072834	Sibel SA Vascular Clamp	Surgical Instruments Belgium SA	2008	—
−1	K110148	Wexler Vascular Clamp Series	Microsurgical Laboratories,Inc.Dba Wexler Surgical	2011	—
0 (this device)	K112662	Microfrance (R) Wormald Vascular Clamp	Medtronic Xomed, Inc.	2012	—

FIG. 1 — Lineage of K112662, 1998–2012Source: 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
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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
*	K110148	Wexler Vascular Clamp Series Summary page 1 …Vascular clamp Name: 21CFR 870.4450, Pro Code DXC, Class 11 Predicate Device: Wexler Vascular Clamp Series KI 110148 (Cleared 04/19/2011) Device MicroFrance® Wormald Vascular Clamps enable a surgeon to Description:…	Microsurgical Laboratories,Inc.Dba Wexler Surgical	2011	—

Also cleared against K110148: 1 other device →

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 14 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K110148.

How does its category compare?

All DXC devices

DXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?

MicroFrance® Wormald Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K112662 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112662: Microfrance (R) Wormald Vascular Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112662

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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