510(k) · Cleared
Recalled · Class II · 2025LimFlow Vector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LimFlow, Inc. · MGZ Valvulotome
Cleared on Dec 21, 2022 as substantially equivalent to K132190 (LeMaitre Vascular, Inc., 2013) after a 174-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 21, 2022
- Review
- 174 days
- Class
- Class II
- Product code
- MGZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K946352 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK946352 Lemaitre Valvulotome IIVascutech, Inc. · 1995
- 2 generations backK080178 Valvulotome by KovenKoven Technology, Inc. · 2008
- 1 generation backK132190 Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre ValvulotomeLeMaitre Vascular, Inc. · 2013
- This deviceK221902 LimFlow VectorLimFlow, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK260188 LimFlow VectorLimFlow, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260188LimFlow VectorLimFlow, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K946352 | Lemaitre Valvulotome II | Vascutech, Inc. | 1995 | — |
| −2 | K080178 | Valvulotome by Koven | Koven Technology, Inc. | 2008 | — |
| −1 | K132190 | Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre Valvulotome | LeMaitre Vascular, Inc. | 2013 | — |
| 0 (this device) | K221902 | LimFlow Vector | LimFlow, Inc. | 2022 | — |
| +1 | K260188 | LimFlow Vector | LimFlow, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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
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 |
|---|---|---|---|
| * | K132190 | Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre ValvulotomeSummary page 4…on: Class II Regulation: 21 CFR 870.4885 Product Code: MGZ Premarket Notification: K132190 Note: This predicate device has not been subject to a recall. 5.4 Device Description The LimFlow Vect… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260188 | LimFlow Vector | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2025 | Class II | Z-1218-2026 | Process control | Incorrect expiration date |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 9.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K260188 (LimFlow, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K132190.
How does its category compare?
All MGZ devicesMGZ Valvulotome: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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/K221902 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221902: 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/K221902
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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