510(k) · Cleared
ClearedModification to Radius Snare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radius Medical Technologies, Inc. · MMX Device, Percutaneous Retrieval
Cleared on Sep 25, 2007 as substantially equivalent to K021441 (Radius Medical Technologies, Inc., 2002) after a 123-day review. Its family tree reaches back 3 generations to 1990. 2 of the 7 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Sep 25, 2007
- Review
- 123 days
- Class
- Class II
- Product code
- MMX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K901502 (1990). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly. 2 of the 7 devices in this family, counting this one, have a Class I recall.
- 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 backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
- This deviceK071457 Modification to Radius SnareRadius Medical Technologies, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK163307 Expro Elite Snare, Sympro Elite SnareVascular Solutions, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK080364 Findrwirz Guide Wire SystemSentreheart, Inc. · 2008 · Recalled (Class I)
Class I recalls in this family
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 |
|---|---|---|---|---|---|
| −3 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −2 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| −1 | K021441 | Radius Snare | Radius Medical Technologies, Inc. | 2002 | — |
| 0 (this device) | K071457 | Modification to Radius Snare | Radius Medical Technologies, Inc. | 2007 | — |
| +1 | K163307 | Expro Elite Snare, Sympro Elite Snare | Vascular Solutions, Inc. | 2017 | — |
| +1 | K080364 | Findrwirz Guide Wire System | Sentreheart, Inc. | 2008 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
| 2017 | 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.
2 devices in this family have 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 |
|---|---|---|---|
| * | K021441 | Radius SnareSummary page 1…ATION Substantial equivalence of the modified Radius Snare is based on Design similarities and Performance testing equivalency to the currently marketed Snare (K021441) The modified Radius Snare and currently marketed Radius Snare (K02 1441) are substantially equivalent in terms of siz… | 2002 |
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? (2 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.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
- 3 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K163307 (Vascular Solutions, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K021441.
How does its category compare?
All MMX devicesMMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Radius Snare is 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071457: Modification to Radius Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071457
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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