510(k) · Cleared
ClearedMicroplex Coil System
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 Oct 29, 2001 as substantially equivalent to K002056 (Micrus Corp., 2001) and 3 other predicates after a 111-day review. Its family tree reaches back 5 generations to 1995. 1 of the 123 devices in its family, counting itself, has a Class I recall. 96 later devices descend from it.
- Decided
- Oct 29, 2001
- Review
- 111 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K951256 (1995). 26 ancestors in all, the oldest K860840 (1986). 96 later devices descend from it, 4 citing it directly. 1 of the 123 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 4 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 3 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 2 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 1 generation backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- This deviceK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 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 · 3 generations on · 66 of its ownK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- Descendant · 3 generations on · 65 of its ownK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K220040 CEREPAK Uniform, Uniform XL, Uniform 3D…5 generations on · 2022
Most influential descendants
Showing 5 of 96 · See all- 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 · 3 generations on66descendants
- K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · 3 generations on65descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −4 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −3 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −2 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −1 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| 0 (this device) | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| +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 | — |
| +3 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| +3 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
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 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 6 | 0 |
| 2009 | 8 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 6 | 0 |
| 2013 | 11 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 1 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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.
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 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? (4)
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 |
|---|---|---|---|
| * | K002056 | Micrus Microcoil Delivery System, MDS03Summary page 2…on of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed: Predicate Company Description Clearance Devices Date K002056 Micrus Corporation Micrus Microcoil Delivery System 1/11/2001 K993417 Target Therapeutics GDC-10 and GDC-18 Guglielmi 1/21/2000 D… | 2001 |
| * | K993417 | GDC-10 Guglielmi Detachable Coil (GDC) (3D Shape GDC), GDC-18 Guglielmi Detachable Coil…Summary page 2…ich substantial equivalence is being claimed: Predicate Company Description Clearance Devices Date K002056 Micrus Corporation Micrus Microcoil Delivery System 1/11/2001 K993417 Target Therapeutics GDC-10 and GDC-18 Guglielmi 1/21/2000 Detachable Coil (3D Shape GDC) K991139 Target Therapeutics Guglielmi De… | 2000 |
| * | K991139 | Guglielmi Detachable (GDC)Summary page 2…te K002056 Micrus Corporation Micrus Microcoil Delivery System 1/11/2001 K993417 Target Therapeutics GDC-10 and GDC-18 Guglielmi 1/21/2000 Detachable Coil (3D Shape GDC) K991139 Target Therapeutics Guglielmi Detachable Coil (GDC) 12/22/1999 K951256 Target Therapeutics Detachable Platinum Coil (Guglielmi 9/… | 1999 |
| * | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Summary page 2…1 K993417 Target Therapeutics GDC-10 and GDC-18 Guglielmi 1/21/2000 Detachable Coil (3D Shape GDC) K991139 Target Therapeutics Guglielmi Detachable Coil (GDC) 12/22/1999 K951256 Target Therapeutics Detachable Platinum Coil (Guglielmi 9/8/1995 Detachable Coil) 4. A description of the device that is the sub… | 1995 |
What descends from it? (96)
See all 964 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft…Medos International SARL · 2022 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K020434 (MicroVention, Inc., 2002) has gone furthest, with 70 descendants of its own.
- 6 other devices also cite its predicate K002056.
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 MicroVention MicroPlex Coil System (MCS) is intended for endovascular 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.
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/K012145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012145: Microplex Coil System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012145
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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