510(k) Report

510(k) · Cleared

Cleared

Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit

K191758510(k) TraditionalCleared Dec 17, 2019169-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

Argon Medical Devices, Inc. · MMX Device, Percutaneous Retrieval

Cleared on Dec 17, 2019 as substantially equivalent to K152560 (Neometrics, Inc., 2015) after a 169-day review. Its family tree reaches back 7 generations to 1990. 1 of the 16 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided
Dec 17, 2019
Review
169 days
Class
Class II
Product code
MMX
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K901502 (1990). 14 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.

  1. Root · 7 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
  2. 6 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
  3. 5 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
  4. 4 generations backK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
  5. 3 generations backK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
  6. 2 generations backK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
  7. 1 generation backK152560 Bard Snare Retrieval KitNeometrics, Inc. · 2015
  8. This deviceK191758 Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc. · 2019
  9. Descendant · cites it directly · 0 of its ownK232443 Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc. · 2023

Class I recalls in this family

Most influential descendants

Showing 1 of 1 · See all
  • K232443Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K901502Amplatz Goose-Neck SnareMicrovena Corp.19901
−6K972511Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp.19981
−5K021441Radius SnareRadius Medical Technologies, Inc.2002—
−4K022201Radius Micro SnareRadius Medical Technologies, Inc.2003—
−3K032426Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc.2003—
−2K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps2008—
−1K152560Bard Snare Retrieval KitNeometrics, Inc.2015—
0 (this device)K191758Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc.2019—
+1K232443Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc.2023—

Other ancestors by year cleared

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
FIG. 1 — Lineage of K191758, 1990–2023Source: 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.

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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K152560Bard Snare Retrieval Kit
Summary page 4
…21 CFR 870.5150 Class II Review Panel: Cardiovascular Devices Predicate Device(s): Primary: K152560 Bard Retrieval Kit Reference: K021606 Atrieve Vascular Snare Kit (formerly known as…
Neometrics, Inc.2015—
†K021606EN-Snare Endovascular Snare and CatheterMedical Device Technologies, Inc.2002—
†K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps2008—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K232443Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc.20230

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

What does this lineage say?

  • The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
  • 3 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K232443 (Argon Medical Devices, Inc., 2023) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MMX devices

MMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?

Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit are intended for the percutaneous removal of retrievable inferior vena cava (IVC) filters that are no longer medically required, via jugular approach.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K191758: Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191758

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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