510(k) · Cleared

Cleared

Radius Snare

K021441510(k) TraditionalCleared Jun 14, 200239-day reviewClass II21 CFR 870.5150

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Radius Medical Technologies, Inc. · MMX Device, Percutaneous Retrieval

Cleared on Jun 14, 2002 as substantially equivalent to K972511 (Microvena Corp., 1998) and 1 other predicate after a 39-day review. Its family tree reaches back 2 generations to 1990. 5 of the 40 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it.

Decided: Jun 14, 2002
Review: 39 days
Class: Class II
Product code: MMX
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K901502 (1990). 3 ancestors in all. 36 later devices descend from it, 2 citing it directly. 5 of the 40 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 2 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
1 generation backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
This deviceK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
Descendant · cites it directly · 32 of its ownK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
Descendant · 2 generations on · 31 of its ownK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
Descendant · 3 generations on · 16 of its ownK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
Descendant · 4 generations on · 6 of its ownK112185 Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · Recalled (Class I)
Descendant · 3 generations on · 6 of its ownK081410 Option Vena Cava FilterRex Medical · 2009

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2003high 3 (2015) · low 0 (2006)2026

Class I recalls in this family

K970466 Radius Ptca Guidewiredirect predicate · 1997
K080364 Findrwirz Guide Wire System2 generations on · 2008
K034050 Cordis Optease Vena Cava Filter, Models…3 generations on · 2004
K091077 Optease Vena Cava Filter and Retrieval Catheter4 generations on · 2010

Most influential descendants

Showing 5 of 36 · See all

K022201Radius Micro SnareRadius Medical Technologies, Inc. · 2003 · cites it directly32descendants
K032426Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003 · 2 generations on31descendants
K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps · 2008 · 3 generations on16descendants
K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 4 generations on6descendants
K081410Option Vena Cava FilterRex Medical · 2009 · 3 generations on6descendants

View 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)	K021441	Radius Snare	Radius Medical Technologies, Inc.	2002	—
+1	K022201	Radius Micro Snare	Radius Medical Technologies, Inc.	2003	—
+2	K032426	Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set	Cook, Inc.	2003	—
+3	K073374	Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set	William Cook Europe Aps	2008	—
+4	K112185	Foursnare Vascular Retrieval Snare	Cook, Inc.	2011	Class I
+3	K081410	Option Vena Cava Filter	Rex Medical	2009	—

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
2003	2	0
2004	1	1
2005	1	0
2007	1	0
2008	2	1
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	3	0
2018	3	0
2019	1	0
2022	3	0
2023	2	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K021441, 1990–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

5 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 11.0 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K972511	Amplatz Goose Neck Snare Kit/ Catheter Summary page 2 …Radius Snare is substantially equivalent in material, design and function to the following predicate devices: the Microvena Amplatz Goose Neck Snare/Catheter (K972511) and the Radius PTCA Guidewire (K970466). The Radius Snare is similar in materials, function and design to predicate Radius…	Microvena Corp.	1998	1
*	K970466	Radius Ptca Guidewire Summary page 1 …Marketed Device The Radius Snare is substantially equivalent to the Microvena Amplatz Goose Neck Snare/Catheter (IS9725 11) Radius PTCA Guidewire (K970466). 4. Device Description The Radius Snare is composed of two primary parts: an outer sheath tube and a core wi…	Radius Medical Technologies, Inc.	1997	Class I

Also cleared against K972511: 6 other devices →

What descends from it? (36)

See all 36

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022201	Radius Micro Snare	Radius Medical Technologies, Inc.	2003	32
K071457	Modification to Radius Snare	Radius Medical Technologies, Inc.	2007	2

Has anything in its family been recalled? (5 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
K080364Findrwirz Guide Wire SystemSentreheart, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter, Model 466-C220FCordis Corporation · 2004 · 3 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 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
K112185Foursnare Vascular Retrieval SnareCook, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
3 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K022201 (Radius Medical Technologies, Inc., 2003) has gone furthest, with 32 descendants of its own.
6 other devices also cite its predicate K972511.

How does its category compare?

All MMX devices

MMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MMX

1in 2025

2007high 3 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMX

151in 2022

2007high 151 (2022)2026

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

2007high 49 (2025) · low 2 (2007)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	MAUDE reports
2007	1	—	2
2008	0	—	6
2009	2	—	6
2010	1	—	11
2011	1	—	15
2012	1	—	13
2013	0	—	10
2014	2	—	11
2015	2	—	5
2016	2	—	16
2017	2	—	29
2018	1	—	15
2019	1	—	17
2020	2	—	14
2021	1	—	22
2022	3	151	37
2023	2	—	40
2024	1	—	32
2025	1	—	49
2026	0	—	—

What is it indicated for?

The Radius Snare is intended for use in the cardiovascular system and hollow viscous to

retrieve andlor manipulate objects using minimally invasive surgical procedures.

Manipulation procedures include retrieval and/or repositioning of intravascular foreign

objects such as coils, balloons, catheters andor guidewires within the cardiovascular

system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021441 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021441: Radius Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021441

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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