510(k) · Cleared
Recalled · 2010Matrix Detachable Coils
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific, Target · HCG Device, Neurovascular Embolization
Cleared on Jan 31, 2002 as substantially equivalent to K001083 (Boston Scientific, Target, 2000) after a 147-day review. Its family tree reaches back 1 generation to 2000. 122 later devices descend from it. It has been recalled 10 times.
- Decided
- Jan 31, 2002
- Review
- 147 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 10
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001083 (2000). 122 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK001083 Guglielmi Detachable Coil and Power Supply, Models Power Supply…Boston Scientific, Target · 2000
- This deviceK012985 Matrix Detachable CoilsBoston Scientific, Target · 2002
- Descendant · cites it directly · 100 of its ownK031168 Matrix Stretch Resistant Detachable CoilBoston Scientific, Target · 2003 · Recalled
- Descendant · cites it directly · 70 of its ownK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- Descendant · 2 generations on · 68 of its ownK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- Descendant · 3 generations on · 67 of its ownK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- Descendant · 2 generations on · 66 of its ownK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
Showing 5 of 122 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 122 · See all- K031168Matrix Stretch Resistant Detachable CoilBoston Scientific, Target · 2003 · cites it directly100descendants
- K020434Microplex Coil System (MCS)MicroVention, Inc. · 2002 · cites it directly70descendants
- K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003 · 2 generations on68descendants
- K033836Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003 · 3 generations on67descendants
- K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004 · 2 generations on66descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001083 | Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4… | Boston Scientific, Target | 2000 | — |
| 0 (this device) | K012985 | Matrix Detachable Coils | Boston Scientific, Target | 2002 | — |
| +1 | K031168 | Matrix Stretch Resistant Detachable Coil | Boston Scientific, Target | 2003 | 10 |
| +1 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| +2 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| +3 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| +2 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 8 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 9 | 0 |
| 2013 | 11 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 HCG? 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 HCG device
- #1 K252700 Optima Coil System (Optima Packing Coil System)score 20.6 · 26 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 |
|---|---|---|---|
| * | K001083 | Guglielmi Detachable Coil and Power Supply, Models Power Supply : 451006-4; Cables…Summary page 1…CFR Section 882.5950) COMMON NAME: Occlusion Coil PROPRIETARY NAME: Matrix™ Detachable Coils PREDICATE DEVICE: Guglielmi Detachable Coil (GDC™) and GDC™ Power Supply (K001083) DEVICE DESCRIPTION: The Matrix™ Detachable Coil system consists of the following, each of which is sold seperately: * GDC™ Syn… | 2000 |
What descends from it? (122)
See all 1224 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 19, 2010 | Not classified | Z-0855-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0856-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0863-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0860-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0862-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0854-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0857-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0858-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0859-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
| Oct 19, 2010 | Not classified | Z-0861-2011 | Process control | The product appears to have premature degradation of the PGLA coating on the Matrix Coil. |
The 5 latest of 10 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HCG
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HCG
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HCG
537in 2025
MAUDE reports naming product code HCG, 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 | 8 | 50 | 1 | 326 |
| 2008 | 9 | 71 | 3 | 730 |
| 2009 | 7 | 48 | 0 | 821 |
| 2010 | 8 | 72 | 2 | 851 |
| 2011 | 9 | 78 | 1 | 894 |
| 2012 | 7 | 30 | 0 | 1,146 |
| 2013 | 7 | 67 | 2 | 1,103 |
| 2014 | 5 | 66 | 4 | 1,729 |
| 2015 | 5 | 60 | 0 | 1,598 |
| 2016 | 7 | 37 | 0 | 1,991 |
| 2017 | 5 | 97 | 0 | 2,494 |
| 2018 | 4 | 173 | 0 | 2,058 |
| 2019 | 1 | — | 0 | 1,763 |
| 2020 | 2 | — | 0 | 1,754 |
| 2021 | 5 | 103 | 0 | 2,268 |
| 2022 | 3 | 114 | 2 | 663 |
| 2023 | 2 | — | 0 | 568 |
| 2024 | 4 | 49 | 1 | 552 |
| 2025 | 3 | 107 | 1 (1) | 537 |
| 2026 | 4 | 30 | 1 | — |
What is it indicated for?
The Matrix™ Detachable Coils have the same indications for use as the predicate GDC coils.
Matrix™ Detachable Coils are intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be:
a) very high risk for management by traditional operative techniques, or,
b) inoperable,
and for embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
The Matrix™ Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
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/K012985 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012985: Matrix Detachable Coils.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012985
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026