510(k) · Cleared
ClearedAesculap Vascular Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · DXC Clamp, Vascular
Cleared on Jan 13, 2000 after a 209-day review. The FDA summary names no predicate by number. 3 later devices descend from it.
- Decided
- Jan 13, 2000
- Review
- 209 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK992053 Aesculap Vascular InstrumentsAesculap, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK092544 Instrumed Vascular ClampsInstrumed International, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK123077 Vascular ClampsHebumedical GmbH · 2013
- Descendant · 2 generations on · 0 of its ownK120492 K2 Medical Vascular ClampsK2 Medical GmbH & Co. KG · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K992053 | Aesculap Vascular Instruments | Aesculap, Inc. | 2000 | — |
| +1 | K092544 | Instrumed Vascular Clamps | Instrumed International, Inc. | 2009 | — |
| +1 | K123077 | Vascular Clamps | Hebumedical GmbH | 2013 | — |
| +2 | K120492 | K2 Medical Vascular Clamps | K2 Medical GmbH & Co. KG | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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?
The FDA summary names no predicate by number.
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?
- Of its descendants, K092544 (Instrumed International, Inc., 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Aesculap's Vascular Clamps and instruments are indicated for use in vascular surgery. Alfa and Alfa-mini vascular clamps are designed for temporary occlusion of blood vessels during open surgical procedures. Atraumatic vascular clamps and clamp appliers/removers are designed for temporary occlusion of blood vessels during either an open or endoscopic surgical approach.
Laparoscopic vascular scissors, forceps, clamps, dissecting spatulas and needleholder are use for cutting, dissecting, clamping, fixation and suturing vessels and tubular structures. Flexible trocars provide access to the surgical site for use in laparoscopic vascular surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992053 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992053: Aesculap Vascular Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992053
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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