510(k) · Cleared

Cleared

Vascular Clamps

K123077510(k) TraditionalCleared May 14, 2013225-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

Cleared on May 14, 2013 as substantially equivalent to K992053 (Aesculap, Inc., 2000) and 1 other predicate after a 225-day review. Its family tree reaches back 2 generations to 1998.

Decided: May 14, 2013
Review: 225 days
Class: Class II
Product code: DXC
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K973080 (1998). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK973080 Surgical Vascular ClampWalter Lorenz Surgical, Inc. · 1998
1 generation backK072834 Sibel SA Vascular ClampSurgical Instruments Belgium SA · 2008
This deviceK123077 Vascular ClampsHebumedical GmbH · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K973080	Surgical Vascular Clamp	Walter Lorenz Surgical, Inc.	1998	—
−1	K072834	Sibel SA Vascular Clamp	Surgical Instruments Belgium SA	2008	—
0 (this device)	K123077	Vascular Clamps	Hebumedical GmbH	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

FIG. 1 — Lineage of K123077, 1998–2013Source: 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? (2)

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
*	K992053	Aesculap Vascular Instruments Summary page 1 …Vascular Clamps Common Name: Vascular Clamp Classification Name: Vascular Clamp Predicate a K992053 - Aesculap Vascular Instruments Device: o K072834 - Sibel Vascular Clamp Device HEBUmedical Vascu…	Aesculap, Inc.	2000	—
*	K072834	Sibel SA Vascular Clamp Summary page 1 …Vascular Clamp Classification Name: Vascular Clamp Predicate a K992053 - Aesculap Vascular Instruments Device: o K072834 - Sibel Vascular Clamp Device HEBUmedical Vascular Clamps are reusable stainless Description: steel ri…	Surgical Instruments Belgium SA	2008	—

Also cleared against K992053: 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 15 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K992053.

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?

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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123077 · printed Nov 5, 2026

Cite this page

510(k) Report. “K123077: Vascular Clamps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123077

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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