510(k) · Cleared
Recalled · Class II · 20161.5MM Hydro Expandable Lemaitre Valvulotome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LeMaitre Vascular, Inc. · MGZ Valvulotome
Cleared on Apr 10, 2014 as substantially equivalent to K132190 (LeMaitre Vascular, Inc., 2013) and 1 other predicate after a 92-day review. Its family tree reaches back 3 generations to 1995. It has been recalled 3 times.
- Decided
- Apr 10, 2014
- Review
- 92 days
- Class
- Class II
- Product code
- MGZ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K946352 (1995). 6 ancestors in all, the oldest K890113 (1989). 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 deviceK140042 1.5MM Hydro Expandable Lemaitre ValvulotomeLeMaitre Vascular, Inc. · 2014
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) | K140042 | 1.5MM Hydro Expandable Lemaitre Valvulotome | LeMaitre Vascular, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1998 | 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? (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 |
|---|---|---|---|
| * | K132190 | Expandable Lemaitre Valvulotome, Over-the-Wire Lemaitre ValvulotomeSummary page 2…Intended Use: It is used for the treatment of vascular disorders, and more particularly for excising or disrupting venous valves. Predicate Devices: 5 10(k): K 132190 (Change to indication) Device Name: Expandable LeMaitre Valvulotome, Over-the-Wire LeMaitre Valvulotome SE Date:… | 2013 |
| * | K980732 | 3M Cdi Quick-Cells with Heparin TreatmentSummary page 2…8/5/20 13 Regulation Number: 21CFR §870.4885 Device Class Name: Valvulotome, External Vein Stripper Device Class: 11 Product Code: MGZ 5 10(k): K980732 Device Name: Expandable LeMaitre Valvulotome SE Date: 2/12/1999 Regulation Number: 2ICFR §870.4885 De… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 3, 2016 | Class II | Z-2544-2016 | Process control | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| Aug 3, 2016 | Class II | Z-2543-2016 | Process control | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| Aug 3, 2016 | Class II | Z-2545-2016 | Process control | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 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. 2014, 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?
It is used 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/K140042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140042: 1.5MM Hydro Expandable Lemaitre Valvulotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140042
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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