510(k) · Cleared
ClearedHalo Single-Loop Microsnare Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argon Medical Devices, Inc. · MMX Device, Percutaneous Retrieval
Cleared on Jan 5, 2021 as substantially equivalent to K970668 (Microvena Corp., 1998) after a 270-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Jan 5, 2021
- Review
- 270 days
- Class
- Class II
- Product code
- MMX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914067 (1991). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914067 | Retrieval Device | Target Therapeutics | 1991 | — |
| −1 | K970668 | The Amplantz Goose Neck Microsnare | Microvena Corp. | 1998 | — |
| 0 (this device) | K200963 | Halo Single-Loop Microsnare Kit | Argon Medical Devices, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 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.
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 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? (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 | Decided |
|---|---|---|---|
| * | K970668 | The Amplantz Goose Neck MicrosnareSummary page 4…21 CFR 870.5150 Class II Review Panel: Cardiovascular Devices Predicate Primary: K970668 Amplatz Goose Neck Microsnare Device(s): Reference: K142265 ONE Snare Endovascular Microsnare Syste… | 1998 |
| † | K142265 | ONE Snare Endovascular Microsnare System | 2014 |
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 3 companies; a new generation was cleared every 22.6 years on median.
- None of the 4 ancestors has a recall.
- 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. 2021, this device’s year, is highlighted.
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 Halo™ Single-Loop Microsnare Kit is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200963: Halo Single-Loop Microsnare Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200963
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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