510(k) · Cleared
ClearedExpro Elite Snare, Sympro Elite Snare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · MMX Device, Percutaneous Retrieval
Cleared on Mar 8, 2017 as substantially equivalent to K071457 (Radius Medical Technologies, Inc., 2007) after a 105-day review. Its family tree reaches back 4 generations to 1990. 1 of the 6 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 8, 2017
- Review
- 105 days
- Class
- Class II
- Product code
- MMX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K901502 (1990). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- 3 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- 2 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
- 1 generation backK071457 Modification to Radius SnareRadius Medical Technologies, Inc. · 2007
- This deviceK163307 Expro Elite Snare, Sympro Elite SnareVascular Solutions, Inc. · 2017
Class I recalls in this family
- K970466 Radius Ptca Guidewire3 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −3 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| −2 | K021441 | Radius Snare | Radius Medical Technologies, Inc. | 2002 | — |
| −1 | K071457 | Modification to Radius Snare | Radius Medical Technologies, Inc. | 2007 | — |
| 0 (this device) | K163307 | Expro Elite Snare, Sympro Elite Snare | Vascular Solutions, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K071457 | Modification to Radius SnareSummary page 4…Usual Name Percutaneous Retrieval Device Classification Name 21 CFR 870.5150, MMX, Percutaneous Retrieval Device, Class II Predicate Device K071457, Expro Elite Snare, Vascular Solutions, Inc. Reference Device K972511, Amplatz Goose Neck Snare Device Description… | 2007 |
| † | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- 3 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K071457.
How does its category compare?
All MMX devicesMMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Expro Elite and Sympro Elite snares are intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system. This device is not intended for use in the coronary arteries or neurovasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163307: Expro Elite Snare, Sympro Elite Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163307
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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