510(k) · Cleared
ClearedK2 Medical Vascular Clamps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K2 Medical GmbH & Co. KG · DXC Clamp, Vascular
Cleared on Apr 30, 2012 as substantially equivalent to K092544 (Instrumed International, Inc., 2009) after a 73-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Apr 30, 2012
- Review
- 73 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022754 (2002). 7 ancestors in all, the oldest K973080 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK022754 S&T Single Use Micro Anastomosis ClampS & T AG · 2002
- 2 generations backK070661 Vitalcor Featherweight Vascular ClampsVitalcor, Inc. · 2007
- 1 generation backK092544 Instrumed Vascular ClampsInstrumed International, Inc. · 2009
- This deviceK120492 K2 Medical Vascular ClampsK2 Medical GmbH & Co. KG · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022754 | S&T Single Use Micro Anastomosis Clamp | S & T AG | 2002 | — |
| −2 | K070661 | Vitalcor Featherweight Vascular Clamps | Vitalcor, Inc. | 2007 | — |
| −1 | K092544 | Instrumed Vascular Clamps | Instrumed International, Inc. | 2009 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K092544 | Instrumed Vascular ClampsSummary page 1…asive Coronary Systems Classification name: Clamp, Vascular (21 CFR 870.4450, Product code DXC) Regulation Description Vascular Clamp. Substantial Equivalence Claims: K092544 INSTRUMED VASCULAR CLAMPS INSTRUMED INTERNATIONAL, INC. 626 Cooper Court Sch… | 2009 |
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 10 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All DXC devicesDXC 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
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?
K2 Medical 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/K120492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120492: K2 Medical Vascular Clamps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120492
Report an extraction error
Are you the manufacturer?
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