510(k) · Cleared
ClearedLimFlow Vector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LimFlow, Inc. · MGZ Valvulotome
Cleared on Mar 18, 2026 as substantially equivalent to K221902 (LimFlow, Inc., 2022) after a 55-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 18, 2026
- Review
- 55 days
- Class
- Class II
- Product code
- MGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K946352 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK946352 Lemaitre Valvulotome IIVascutech, Inc. · 1995
- 3 generations backK080178 Valvulotome by KovenKoven Technology, Inc. · 2008
- 2 generations backK132190 Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre ValvulotomeLeMaitre Vascular, Inc. · 2013
- 1 generation backK221902 LimFlow VectorLimFlow, Inc. · 2022 · Recalled
- This deviceK260188 LimFlow VectorLimFlow, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K946352 | Lemaitre Valvulotome II | Vascutech, Inc. | 1995 | — |
| −3 | K080178 | Valvulotome by Koven | Koven Technology, Inc. | 2008 | — |
| −2 | K132190 | Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre Valvulotome | LeMaitre Vascular, Inc. | 2013 | — |
| −1 | K221902 | LimFlow Vector | LimFlow, Inc. | 2022 | 1 |
| 0 (this device) | K260188 | LimFlow Vector | LimFlow, Inc. | 2026 | — |
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 K250105 Boomerang Valvulotome (BMGVT080); Boomerang…score 10.2 · 3 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K221902 | LimFlow VectorSummary page 5…Device, External Vein Stripper Product Classification number 21 CFR 870.4885 Product code MGZ Regulatory class II Predicate device LimFlow Vector (K221902) Description The LimFlow Vector is a single-use medical device designed to cut venous valves du… | 2022 |
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 31 years and passes through 4 companies; a new generation was cleared every 9.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All MGZ devicesMGZ Valvulotome: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 LimFlow Vector is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260188: LimFlow Vector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260188
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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