510(k) · Cleared
ClearedWexler Vascular Clamp Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microsurgical Laboratories,Inc.Dba Wexler Surgical · DXC Clamp, Vascular
Cleared on Apr 19, 2011 as substantially equivalent to K072834 (Surgical Instruments Belgium SA, 2008) after a 91-day review. Its family tree reaches back 2 generations to 1998. 3 later devices descend from it.
- Decided
- Apr 19, 2011
- Review
- 91 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K973080 (1998). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK973080 Surgical Vascular ClampWalter Lorenz Surgical, Inc. · 1998
- 1 generation backK072834 Sibel SA Vascular ClampSurgical Instruments Belgium SA · 2008
- This deviceK110148 Wexler Vascular Clamp SeriesMicrosurgical Laboratories,Inc.Dba Wexler Surgical · 2011
- Descendant · cites it directly · 1 of its ownK123571 Cardio Vision Mics Aortic ClampsCardiomedical GmbH · 2013
- Descendant · 2 generations on · 0 of its ownK210006 MI DeTACHBiorep Technologies, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK112662 Microfrance (R) Wormald Vascular ClampMedtronic Xomed, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See allView 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) | K110148 | Wexler Vascular Clamp Series | Microsurgical Laboratories,Inc.Dba Wexler Surgical | 2011 | — |
| +1 | K123571 | Cardio Vision Mics Aortic Clamps | Cardiomedical GmbH | 2013 | — |
| +2 | K210006 | MI DeTACH | Biorep Technologies, Inc. | 2021 | — |
| +1 | K112662 | Microfrance (R) Wormald Vascular Clamp | Medtronic Xomed, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 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 |
|---|---|---|---|
| * | K072834 | Sibel SA Vascular ClampSummary page 1…scular Clamp (21 CER 870.4450, Product Code DXC) Legally Marketed Device to which Equivalence is Claimed: The legally marketed predicate device is the Vascular Clamp (K(072834) manufactured by Surgical Instruments Belgium (SIBEL) SA, determined to be substantially equivalent to a legally marketed (preAme… | 2008 |
What descends from it? (3)
2 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K123571 (Cardiomedical GmbH, 2013) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K072834.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Wexler Vascular Clamp Series is 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/K110148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110148: Wexler Vascular Clamp Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110148
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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