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 Jan 17, 2020 as substantially equivalent to K122088 (Merit Medical Systems, Inc., 2012) after a 30-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Jan 17, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- MMX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K901502 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- 2 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- 1 generation backK122088 Merit One Snare SystemMerit Medical Systems, Inc. · 2012
- This deviceK193507 Merit ONE Snare SystemMerit Medical Systems, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −2 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| −1 | K122088 | Merit One Snare System | Merit Medical Systems, Inc. | 2012 | — |
| 0 (this device) | K193507 | Merit ONE Snare System | Merit Medical Systems, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K122088 | Merit One Snare SystemSummary page 4…Merit One Snare Endovascular Snare System Predicate Classification Name: 21 CFR 870.5150 Device Premarket Notification: K122088 Manufacturer: Merit Medical Systems, Inc. Class II 21 CFR 87… | 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 30 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K122088.
How does its category compare?
All MMX devicesMMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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/K193507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193507: 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/K193507
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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