510(k) · Cleared
ClearedMerit One Snare 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 Dec 5, 2012 as substantially equivalent to K972511 (Microvena Corp., 1998) after a 142-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it.
- Decided
- Dec 5, 2012
- Review
- 142 days
- Class
- Class II
- Product code
- MMX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K901502 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- 1 generation backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- This deviceK122088 Merit One Snare SystemMerit Medical Systems, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK213494 Aveir Retrieval CatheterAbbott Medical · 2022
- Descendant · cites it directly · 0 of its ownK193507 Merit ONE Snare SystemMerit Medical Systems, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −1 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| 0 (this device) | K122088 | Merit One Snare System | Merit Medical Systems, Inc. | 2012 | — |
| +1 | K213494 | Aveir Retrieval Catheter | Abbott Medical | 2022 | — |
| +1 | K193507 | Merit ONE Snare System | Merit Medical Systems, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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 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 10.9 · 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 |
|---|---|---|---|
| * | K972511 | Amplatz Goose Neck Snare Kit/ CatheterSummary page 1…Predicate CATHETER Devce Classification Name: catheter, embolectomy Devce Premarket Notification: K97251 1 Manufacturer: ev3 Inc. Class 11 Classification 21 CIFR § 870.5150… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 2 companies; a new generation was cleared every 14.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K213494 (Abbott Medical, 2022) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K972511.
How does its category compare?
All MMX devicesMMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 TM endovascular snare system is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects.
Retrieval and manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access venipuncture procedure assistance
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122088: Merit One Snare System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122088
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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