510(k) · Cleared
ClearedMicroplex Coil System (MCS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · HCG Device, Neurovascular Embolization
Cleared on Jul 29, 2002 as substantially equivalent to K993417 (Boston Scientific, Target, 2000) and 2 other predicates after a 171-day review. Its family tree reaches back 6 generations to 1995. 70 later devices descend from it.
- Decided
- Jul 29, 2002
- Review
- 171 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K951256 (1995). 29 ancestors in all, the oldest K860840 (1986). 70 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 5 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 4 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 3 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 2 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 1 generation backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- This deviceK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- Descendant · cites it directly · 68 of its ownK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- Descendant · 2 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
- Descendant · 2 generations on · 65 of its ownK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- Descendant · 3 generations on · 36 of its ownK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K032590Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003 · cites it directly68descendants
- K033836Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003 · 2 generations on67descendants
- K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004 · 2 generations on66descendants
- K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · 2 generations on65descendants
- K070656Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007 · 3 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −5 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −4 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −3 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −2 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −1 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| 0 (this device) | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| +1 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| +2 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| +2 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| +2 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| +3 | K070656 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 5 | 0 |
| 2013 | 11 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K993417 | GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…Summary page 2…itional model numbers is substantially equivalent to the Guglielmi Detachable Coil (GDC) that was determined to be substantially equivalent on January 21,2000 (reference K993417), the MicroPlex Coil System (MCS) that was determined to be substantially equivalent on October 29,2001 (reference K012145) and t… | 2000 |
| * | K012145 | Microplex Coil SystemSummary page 2…ially equivalent on January 21,2000 (reference K993417), the MicroPlex Coil System (MCS) that was determined to be substantially equivalent on October 29,2001 (reference K012145) and the Matrix Detachable Coil System that was determined to be substantially equivalent on February 1, 2001 (reference KO 12985… | 2001 |
| * | K012985 | Matrix Detachable Coils | 2002 |
What descends from it? (70)
See all 702 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)
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 7 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K032590 (MicroVention, Inc., 2003) has gone furthest, with 68 descendants of its own.
- 2 other devices also cite its predicate K993417.
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 MicroPlex Coil System (MCS) is 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 very high risk for management by traditional operative techniques or inoperable. The MCS is also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020434: Microplex Coil System (MCS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020434
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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