510(k) · Cleared
ClearedRadius Micro 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 Feb 3, 2003 as substantially equivalent to K970668 (Microvena Corp., 1998) and 2 other predicates after a 213-day review. Its family tree reaches back 3 generations to 1990. 4 of the 41 devices in its family, counting itself, have a Class I recall. 32 later devices descend from it.
- Decided
- Feb 3, 2003
- Review
- 213 days
- Class
- Class II
- Product code
- MMX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K901502 (1990). 8 ancestors in all. 32 later devices descend from it, 1 citing it directly. 4 of the 41 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 deviceK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
- Descendant · cites it directly · 31 of its ownK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
- Descendant · 2 generations on · 16 of its ownK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
- Descendant · 3 generations on · 6 of its ownK112185 Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK081410 Option Vena Cava FilterRex Medical · 2009
- Descendant · 2 generations on · 5 of its ownK034050 Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B…Cordis Corporation · 2004 · Recalled (Class I)
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 32 · See all- K032426Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003 · cites it directly31descendants
- K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps · 2008 · 2 generations on16descendants
- K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 3 generations on6descendants
- K081410Option Vena Cava FilterRex Medical · 2009 · 2 generations on6descendants
- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter…Cordis Corporation · 2004 · 2 generations on5descendants
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 | K021441 | Radius Snare | Radius Medical Technologies, Inc. | 2002 | — |
| 0 (this device) | K022201 | Radius Micro Snare | Radius Medical Technologies, Inc. | 2003 | — |
| +1 | K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | Cook, Inc. | 2003 | — |
| +2 | K073374 | Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set | William Cook Europe Aps | 2008 | — |
| +3 | K112185 | Foursnare Vascular Retrieval Snare | Cook, Inc. | 2011 | Class I |
| +2 | K081410 | Option Vena Cava Filter | Rex Medical | 2009 | — |
| +2 | K034050 | Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable… | Cordis Corporation | 2004 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1997 | 1 | 1 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 1 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 1 |
| 2011 | 1 | 1 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
4 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? (3)
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 Microsnare Our reading of the summary gave K970688, FDA’s number for Pocket Rescue (Cheen Houng Ent. Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Microvena Amplatz Goose Neck Micro Snare”. | 1998 |
| * | K021441 | Radius SnareSummary page 1…e or Legally Marketed Device The Radius Micro Snare is substantially equivalent to the Microvena Amplatz Goose Neck Micro Snare (K970688), the Radius Snare (K021441) and the Radius PTCA Guidewire (K970466). 4. Device Description The Radius Micro Snare is composed of two prima… | 2002 |
| * | K970466 | Radius Ptca GuidewireSummary page 1…Micro Snare is substantially equivalent to the Microvena Amplatz Goose Neck Micro Snare (K970688), the Radius Snare (K021441) and the Radius PTCA Guidewire (K970466). 4. Device Description The Radius Micro Snare is composed of two primary parts: an outer sheath tube and a cor… | 1997 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | 2003 | 31 |
Has anything in its family been recalled? (4 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 · Direct predicate · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
- K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220FCordis Corporation · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 3 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K032426 (Cook, Inc., 2003) has gone furthest, with 31 descendants of its own.
- 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.
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 Micro Snare is intended for use to retrieve and/or manipulate objects in the distal peripheral vessels of the cardiovascular system and hollow viscus. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the peripheral and cardiovascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022201: Radius Micro Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022201
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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