510(k) · Cleared
ClearedSibel SA Vascular Clamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Instruments Belgium SA · DXC Clamp, Vascular
Cleared on Jan 9, 2008 as substantially equivalent to K973080 (Walter Lorenz Surgical, Inc., 1998) after a 98-day review. Its family tree reaches back 1 generation to 1998. 7 later devices descend from it.
- Decided
- Jan 9, 2008
- Review
- 98 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973080 (1998). 7 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK973080 Surgical Vascular ClampWalter Lorenz Surgical, Inc. · 1998
- This deviceK072834 Sibel SA Vascular ClampSurgical Instruments Belgium SA · 2008
- Descendant · cites it directly · 3 of its ownK110148 Wexler Vascular Clamp SeriesMicrosurgical Laboratories,Inc.Dba Wexler Surgical · 2011
- Descendant · 2 generations on · 1 of its ownK123571 Cardio Vision Mics Aortic ClampsCardiomedical GmbH · 2013
- Descendant · cites it directly · 1 of its ownK092544 Instrumed Vascular ClampsInstrumed International, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK210006 MI DeTACHBiorep Technologies, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK123077 Vascular ClampsHebumedical GmbH · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K110148Wexler Vascular Clamp SeriesMicrosurgical Laboratories,Inc.Dba Wexler Surgical · 2011 · cites it directly3descendants
- K123571Cardio Vision Mics Aortic ClampsCardiomedical GmbH · 2013 · 2 generations on1descendant
- K092544Instrumed Vascular ClampsInstrumed International, Inc. · 2009 · cites it directly1descendant
- K210006MI DeTACHBiorep Technologies, Inc. · 2021 · 3 generations on0descendants
- K123077Vascular ClampsHebumedical GmbH · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973080 | Surgical Vascular Clamp | Walter Lorenz Surgical, Inc. | 1998 | — |
| 0 (this device) | K072834 | Sibel SA Vascular Clamp | Surgical Instruments Belgium SA | 2008 | — |
| +1 | K110148 | Wexler Vascular Clamp Series | Microsurgical Laboratories,Inc.Dba Wexler Surgical | 2011 | — |
| +2 | K123571 | Cardio Vision Mics Aortic Clamps | Cardiomedical GmbH | 2013 | — |
| +1 | K092544 | Instrumed Vascular Clamps | Instrumed International, Inc. | 2009 | — |
| +3 | K210006 | MI DeTACH | Biorep Technologies, Inc. | 2021 | — |
| +1 | K123077 | Vascular Clamps | Hebumedical GmbH | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2021 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K973080 | Surgical Vascular ClampSummary page 3…Feature Vascular Clamp Surgical Vascular Clamp 510(k) Number K072834 K973080 Manufacturer Surgical Instruments Belgium SA Walter Lorenz Surgical, Inc. Classification # & 870.4450… | 1998 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DXC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXC
215in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXC
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXC
442in 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 Vascular Clamp is 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/K072834 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072834: Sibel SA Vascular Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072834
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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