510(k) Report

510(k) · Cleared

Recalled · Class I · 2014

Foursnare Vascular Retrieval Snare

K112185510(k) TraditionalCleared Nov 2, 201196-day reviewClass II21 CFR 870.5150Recalls 1 (1 Class I)

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

Cook, Inc. · MMX Device, Percutaneous Retrieval

Cleared on Nov 2, 2011 as substantially equivalent to K092343 (Merit Medical Systems, Inc., 2009) and 1 other predicate after a 96-day review. Its family tree reaches back 6 generations to 1990. 2 of the 22 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled once, including a Class I recall.

Decided
Nov 2, 2011
Review
96 days
Class
Class II
Product code
MMX
Recalls
1 (1 Class I)
Predicates
2

Its longest line of descent runs back 6 generations to K901502 (1990). 15 ancestors in all. 6 later devices descend from it, 4 citing it directly. 2 of the 22 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2007: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestor, 1 with a Class I recall11993: 2 other ancestors1991: 1 other ancestor2017: 1 descendant cleared2016: 2 descendants cleared2022: 2 descendants cleared2025: 1 descendant clearedK901502 · Amplatz Goose-Neck Snare · Microvena Corp. · 1990 · recalledK972511 · Amplatz Goose Neck Snare Kit/ Catheter · Microvena Corp. · 1998 · recalledK021441 · Radius Snare · Radius Medical Technologies, Inc. · 2002K022201 · Radius Micro Snare · Radius Medical Technologies, Inc. · 2003K032426 · Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set · Cook, Inc. · 2003K073374 · Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set · William Cook Europe Aps · 20081990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 2 other ancestors4 generations back: 4 other ancestors, 1 with a Class I recall1 1 generation forward: 4 descendants2 generations forward: 2 descendants K073374 · Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set · William Cook Europe Aps · 2008K032426 · Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set · Cook, Inc. · 2003K022201 · Radius Micro Snare · Radius Medical Technologies, Inc. · 2003K021441 · Radius Snare · Radius Medical Technologies, Inc. · 2002K972511 · Amplatz Goose Neck Snare Kit/ Catheter · Microvena Corp. · 1998 · recalledK901502 · Amplatz Goose-Neck Snare · Microvena Corp. · 1990 · recalled−50
  1. Root · 6 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
  2. 5 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
  3. 4 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
  4. 3 generations backK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
  5. 2 generations backK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
  6. 1 generation backK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
  7. This deviceK112185 Foursnare Vascular Retrieval SnareCook, Inc. · 2011
  8. Descendant · cites it directly · 1 of its ownK222083 LimFlow V-CeiverLimFlow, Inc. · 2022
  9. Descendant · cites it directly · 1 of its ownK170987 Captus Vascular Retrieval SystemAvantec Vascular Corporation · 2017
  10. Descendant · 2 generations on · 0 of its ownK242776 LimFlow V-CeiverLimFlow, Inc. · 2025
  11. Descendant · 2 generations on · 0 of its ownK212988 ONO Retrieval DeviceOnocor Vascular, LLC · 2022
  12. Descendant · cites it directly · 0 of its ownK160593 Indy OTW Vascular RetrieverCook Incorporated · 2016

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2016: 22017: 12022: 22025: 1
2016high 2 (2016) · low 0 (2018)2026

Class I recalls in this family

  • K970466 Radius Ptca Guidewire4 generations back · 1997

Most influential descendants

Showing 5 of 6 · See all
  • K222083LimFlow V-CeiverLimFlow, Inc. · 2022 · cites it directly1descendant
  • K170987Captus Vascular Retrieval SystemAvantec Vascular Corporation · 2017 · cites it directly1descendant
  • K242776LimFlow V-CeiverLimFlow, Inc. · 2025 · 2 generations on0descendants
  • K212988ONO Retrieval DeviceOnocor Vascular, LLC · 2022 · 2 generations on0descendants
  • K160593Indy OTW Vascular RetrieverCook Incorporated · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K901502Amplatz Goose-Neck SnareMicrovena Corp.19901
−5K972511Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp.19981
−4K021441Radius SnareRadius Medical Technologies, Inc.2002—
−3K022201Radius Micro SnareRadius Medical Technologies, Inc.2003—
−2K032426Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc.2003—
−1K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps2008—
0 (this device)K112185Foursnare Vascular Retrieval SnareCook, Inc.2011—
+1K222083LimFlow V-CeiverLimFlow, Inc.2022—
+1K170987Captus Vascular Retrieval SystemAvantec Vascular Corporation2017—
+2K242776LimFlow V-CeiverLimFlow, Inc.2025—
+2K212988ONO Retrieval DeviceOnocor Vascular, LLC2022—
+1K160593Indy OTW Vascular RetrieverCook Incorporated2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199320
199711
199810
200010
200210
200710
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201620
201710
202220
202510
FIG. 1 — Lineage of K112185, 1990–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242776 LimFlow V-Ceiverscore 10.9 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K092343EN Snare Endovascular Snare System
Summary page 1
…lar Retrieval Snare, or VRS, is substantially equivalent to the EN Snare Endovascular Snare System originally manufactured by Merit Medical under 510(k) clearance number K092343 and the Giinther Tulip Vena-Cava Filter Retrieval Set originally manufactured by Cook Incorporated under 510(k) clearance number…
Merit Medical Systems, Inc.2009—
*K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps2008—

Also cleared against K092343: 3 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K222083LimFlow V-CeiverLimFlow, Inc.20221
K170987Captus Vascular Retrieval SystemAvantec Vascular Corporation20171
K160593Indy OTW Vascular RetrieverCook Incorporated20160
K152136Recovery Cone Removal SystemC.R. Bard, Inc.20160

Has anything in its family been recalled? (2 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 17, 2014Class IZ-2243-2014Device DesignThis remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.

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 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls

What does this lineage say?

  • The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
  • 3 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K222083 (LimFlow, Inc., 2022) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K092343.

How does its category compare?

All MMX devices

MMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · MMX

1in 2025

2007: 12009: 22010: 12011: 12012: 12014: 22015: 22016: 22017: 22018: 12019: 12020: 22021: 12022: 32023: 22024: 12025: 1
2007high 3 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MMX

151in 2022

2022: 151 days median
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

2007: 22008: 62009: 62010: 112011: 152012: 132013: 102014: 112015: 52016: 162017: 292018: 152019: 172020: 142021: 222022: 372023: 402024: 322025: 49
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—02
20080—06
20092—06
20101—011
20111—015
20121—013
20130—010
20142—011
20152—05
20162—016
20172—029
20181—015
20191—017
20202—014
20211—022
20223151037
20232—040
20241—032
20251—049
20260—0—

What is it indicated for?

The Vascular Retrieval Snare is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including, but not limited to, wire guides, coils, balloons, catheters, and filters.

Indications for use as stated in the FDA summary.

Also cleared against K092343

3 other devices cite the same predicate.

  • K213494Aveir Retrieval CatheterAbbott Medical · 2022
  • K170987Captus Vascular Retrieval SystemAvantec Vascular Corporation · 2017
  • K151497EN Snare Endovascular Snare SystemMerit Medical Systems, Inc. · 2015

More from Cook, Inc.

285 FDA decisions under this applicant name. See the company

  • P020018/S070Zenith Fenestrated AAA Endovascular Graft, Zenith Iliac BranchCook, Inc. · 2026
  • P020018/S069Zenith® Flex AAA Endovascular System; Zenith Fenestrated AAA Endovascular Graft (ZFEN); Zenith Iliac Branch…Cook, Inc. · 2026
  • P020018/S068Zenith (Flex) AAA Endovascular Graft; Zenith Renu AAA Ancillary Graft; Zenith Fenestrated AAA Endovascular…Cook, Inc. · 2026
  • P020018/S067Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter; Zenith…Cook, Inc. · 2026
  • P020018/S066Zenith Flex AAA Endovascular System and Zenith Iliac BranchCook, Inc. · 2026

Recent decisions in MMX

The MMX category page

  • K242776LimFlow V-CeiverLimFlow, Inc. · 2025
  • K241259Amplatz Goose Neck Snare KitMedtronic, Inc. · 2024
  • K232443Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc. · 2023
  • K222254Gunther Tulip Vena Cava Filter Retrieval SetCook Incorporated · 2023
  • K222083LimFlow V-CeiverLimFlow, Inc. · 2022

https://510kreport.com/device/K112185 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112185: Foursnare Vascular Retrieval Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112185

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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