510(k) · Cleared
ClearedMI DeTACH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biorep Technologies, Inc. · DXC Clamp, Vascular
Cleared on Mar 4, 2021 as substantially equivalent to K010727 (Novare Surgical Systems, Inc., 2002) and 1 other predicate after a 59-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Mar 4, 2021
- Review
- 59 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K973080 (1998). 7 ancestors in all, the oldest K810162 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK973080 Surgical Vascular ClampWalter Lorenz Surgical, Inc. · 1998
- 3 generations backK072834 Sibel SA Vascular ClampSurgical Instruments Belgium SA · 2008
- 2 generations backK110148 Wexler Vascular Clamp SeriesMicrosurgical Laboratories,Inc.Dba Wexler Surgical · 2011
- 1 generation backK123571 Cardio Vision Mics Aortic ClampsCardiomedical GmbH · 2013
- This deviceK210006 MI DeTACHBiorep Technologies, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973080 | Surgical Vascular Clamp | Walter Lorenz Surgical, Inc. | 1998 | — |
| −3 | K072834 | Sibel SA Vascular Clamp | Surgical Instruments Belgium SA | 2008 | — |
| −2 | K110148 | Wexler Vascular Clamp Series | Microsurgical Laboratories,Inc.Dba Wexler Surgical | 2011 | — |
| −1 | K123571 | Cardio Vision Mics Aortic Clamps | Cardiomedical GmbH | 2013 | — |
| 0 (this device) | K210006 | MI DeTACH | Biorep Technologies, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 2002 | 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? (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 | Decided |
|---|---|---|---|
| * | K010727 | Flexline ClampSummary page 5…= III. PREDICATE DEVICE INFORMATION MI DeTACH® is substantially equivalent in function and intended use to Flexline Clamp (now known as Cygnet® Flexible Clamp) (K010727) and the Cardio Vision® MICS Aortic Clamps (K123571). IV. INDICATIONS FOR USE The MI DeTACH® is indicated for use for… | 2002 |
| * | K123571 | Cardio Vision Mics Aortic ClampsSummary page 5…ubstantially equivalent in function and intended use to Flexline Clamp (now known as Cygnet® Flexible Clamp) (K010727) and the Cardio Vision® MICS Aortic Clamps (K123571). IV. INDICATIONS FOR USE The MI DeTACH® is indicated for use for temporary or partial occlusion of blood vessels dur… | 2013 |
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 23 years and passes through 5 companies; a new generation was cleared every 7.6 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. 2021, 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 MI DeTACH® is indicated for use for temporary or partial occlusion of blood vessels during cardiovascular surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210006: MI DeTACH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210006
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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