510(k) · Cleared

Cleared

Halo™ Single-Loop Snare Kit

K200268510(k) TraditionalCleared Jun 3, 2020121-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 Jun 3, 2020 as substantially equivalent to K972511 (Microvena Corp., 1998) after a 121-day review. Its family tree reaches back 2 generations to 1990.

Decided: Jun 3, 2020
Review: 121 days
Class: Class II
Product code: MMX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K901502 (1990). No later device cites it as a predicate yet.

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 deviceK200268 Halo™ Single-Loop Snare KitArgon Medical Devices, Inc. · 2020

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)	K200268	Halo™ Single-Loop Snare Kit	Argon Medical Devices, Inc.	2020	—

FIG. 1 — Lineage of K200268, 1990–2020Source: 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.

Planning a device in MMX? 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

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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	Applicant	Decided	Recalls
*	K972511	Amplatz Goose Neck Snare Kit/ Catheter Summary page 4 …21 CFR 870.5150 Class II Review Panel: Cardiovascular Devices Predicate Device(s): Primary: K972511 Amplatz Goose Neck Snare Kit/Catheter Reference: K122088 Merit ONE Snare™ Endovascular Snare Syste…	Microvena Corp.	1998	1
†	K122088	Merit One Snare System	Merit Medical Systems, Inc.	2012	—

Also cleared against K972511: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 30 years and passes through 2 companies; a new generation was cleared every 22.2 years on median.
2 of the 2 ancestors have a recall of any class.
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. 2020, this device’s year, is highlighted.

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 Halo™ Single-Loop Snare Kit is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K200268 · printed Nov 5, 2026

Cite this page

510(k) Report. “K200268: Halo™ Single-Loop Snare Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K200268

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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