510(k) · Cleared
ClearedBoomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aveera Medical, Inc. · MGZ Valvulotome
Cleared on Jul 3, 2025 as substantially equivalent to K132190 (LeMaitre Vascular, Inc., 2013) after a 169-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jul 3, 2025
- Review
- 169 days
- Class
- Class II
- Product code
- MGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K946352 (1995). No later device cites it as a predicate yet.
- 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 deviceK250105 Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome…Aveera Medical, Inc. · 2025
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) | K250105 | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) | Aveera Medical, Inc. | 2025 | — |
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 5…sification: Class II Regulation: 21 CFR Part 870.4885 Product Code: MGZ Premarket Notification: K132190 1.4 Device Description The Boomerang™ Valvulotome is a sterile, single-use, non-coated intravascular cathet… | 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 30 years and passes through 4 companies; a new generation was cleared every 11.9 years on median.
- None of the 3 ancestors has a recall.
- 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. 2025, 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 Boomerang™ Valvulotome 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/K250105 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250105: Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250105
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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