510(k) · Cleared
ClearedONE Snare Endovascular Microsnare System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · MMX Device, Percutaneous Retrieval
Cleared on Nov 13, 2014 as substantially equivalent to K970668 (Microvena Corp., 1998) after a 90-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Nov 13, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- MMX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914067 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914067 | Retrieval Device | Target Therapeutics | 1991 | — |
| −1 | K970668 | The Amplantz Goose Neck Microsnare | Microvena Corp. | 1998 | — |
| 0 (this device) | K142265 | ONE Snare Endovascular Microsnare System | Merit Medical Systems, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 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 MMX? 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 MMX device
- #1 K242776 LimFlow V-Ceiverscore 11.0 · 8 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 |
|---|---|---|---|
| * | K970668 | The Amplantz Goose Neck MicrosnareSummary page 4…Trade Name: Amplantz “GOOSE NECK” Microsnare Classification Name: Catheter, Percutaneous Premarket Notification: K970668 Predicate Manufacturer: ev3 (Microvena Corp.) Device Reference Device# 2: Trade… | 1998 |
| † | K122088 | Merit One Snare System | 2012 |
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 23 years and passes through 3 companies; a new generation was cleared every 16.4 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K970668.
How does its category compare?
All MMX devicesMMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MMX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMX
151in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMX
No recall names MMX since 2007.
Adverse event reports per year · MMX
49in 2025
MAUDE reports naming product code MMX, 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 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 2 | — | 0 | 11 |
| 2015 | 2 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 16 |
| 2017 | 2 | — | 0 | 29 |
| 2018 | 1 | — | 0 | 15 |
| 2019 | 1 | — | 0 | 17 |
| 2020 | 2 | — | 0 | 14 |
| 2021 | 1 | — | 0 | 22 |
| 2022 | 3 | 151 | 0 | 37 |
| 2023 | 2 | — | 0 | 40 |
| 2024 | 1 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 49 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ONE Snare Endovascular Microsnare System is intended for use in adult and pediatric populations for the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142265 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142265: ONE Snare Endovascular Microsnare System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142265
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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