510(k) · Cleared
ClearedValvulotome by Koven
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koven Technology, Inc. · MGZ Valvulotome
Cleared on Jul 28, 2008 as substantially equivalent to K946352 (Vascutech, Inc., 1995) after a 186-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- Jul 28, 2008
- Review
- 186 days
- Class
- Class II
- Product code
- MGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946352 (1995). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK946352 Lemaitre Valvulotome IIVascutech, Inc. · 1995
- This deviceK080178 Valvulotome by KovenKoven Technology, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK132190 Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre ValvulotomeLeMaitre Vascular, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK221902 LimFlow VectorLimFlow, Inc. · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK260188 LimFlow VectorLimFlow, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250105 Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome…Aveera Medical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK140042 1.5MM Hydro Expandable Lemaitre ValvulotomeLeMaitre Vascular, Inc. · 2014 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K132190Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre ValvulotomeLeMaitre Vascular, Inc. · 2013 · cites it directly4descendants
- K221902LimFlow VectorLimFlow, Inc. · 2022 · 2 generations on1descendant
- K260188LimFlow VectorLimFlow, Inc. · 2026 · 3 generations on0descendants
- K250105Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)Aveera Medical, Inc. · 2025 · 2 generations on0descendants
- K1400421.5MM Hydro Expandable Lemaitre ValvulotomeLeMaitre Vascular, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946352 | Lemaitre Valvulotome II | Vascutech, Inc. | 1995 | — |
| 0 (this device) | K080178 | Valvulotome by Koven | Koven Technology, Inc. | 2008 | — |
| +1 | K132190 | Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre Valvulotome | LeMaitre Vascular, Inc. | 2013 | — |
| +2 | K221902 | LimFlow Vector | LimFlow, Inc. | 2022 | 1 |
| +3 | K260188 | LimFlow Vector | LimFlow, Inc. | 2026 | — |
| +2 | K250105 | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) | Aveera Medical, Inc. | 2025 | — |
| +2 | K140042 | 1.5MM Hydro Expandable Lemaitre Valvulotome | LeMaitre Vascular, Inc. | 2014 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 MGZ? 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 MGZ device
- #1 K260188 LimFlow Vectorscore 11.9 · 4 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 |
|---|---|---|---|
| * | K946352 | Lemaitre Valvulotome IISummary page 1…The Valvulotome by Koven is substantially equivalent to other Valvulotome devices in the market such as the Lemaitre Valvulotome II, K946352, manufactured by Vascutech, Inc., North Andover, MA 01854. 4. Indications for Use Statemen… | 1995 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132190 | Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre Valvulotome | 2013 | 4 |
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?
- Its one ancestor has no recall.
- Of its descendants, K132190 (LeMaitre Vascular, Inc., 2013) has gone furthest, with 4 descendants of its own.
How does its category compare?
All MGZ devicesMGZ Valvulotome: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MGZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MGZ
Too few MGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · MGZ
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGZ
8in 2025
MAUDE reports naming product code MGZ, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 21 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 1 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 23 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 8 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Valvulotome by Koven is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves when performing in-situ vascular procedures, such as lower extremity arterial bypass surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080178 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080178: Valvulotome by Koven.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080178
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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