510(k) · Cleared
Recalled · Class II · 2019MicroPlex Coil System (MCS) - HyperSoft 3D
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 Aug 31, 2016 as substantially equivalent to K131948 (MicroVention, Inc., 2013) and 1 other predicate after a 97-day review. Its family tree reaches back 18 generations to 1995. It has been recalled once.
- Decided
- Aug 31, 2016
- Review
- 97 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 18 generations to K951256 (1995). 60 ancestors in all, the oldest K860840 (1986). No later device cites it as a predicate yet.
- Root · 18 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 14 generations between
- 3 generations backK111451 Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V…MicroVention, Inc. · 2011
- 2 generations backK132952 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2013 · Recalled
- 1 generation backK153594 MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc. · 2016 · Recalled
- This deviceK161452 MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc. · 2016
Show all 18 generations
- Root · 18 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 17 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 16 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 15 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 14 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 13 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 12 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 11 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 10 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 9 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 8 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 7 generations backK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
- 6 generations backK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
- 5 generations backK090357 Hydroframe (Hes)MicroVention, Inc. · 2009 · Recalled
- 4 generations backK103758 Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc. · 2011 · Recalled
- 3 generations backK111451 Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V…MicroVention, Inc. · 2011
- 2 generations backK132952 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2013 · Recalled
- 1 generation backK153594 MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc. · 2016 · Recalled
- This deviceK161452 MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −17 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −16 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −15 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −14 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −13 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −12 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −11 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −10 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −9 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| −8 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| −7 | K070656 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2007 | — |
| −6 | K080666 | Hydrosoft and Hydrosoft Plus Embolization Coil Systems | MicroVention, Inc. | 2008 | — |
| −5 | K090357 | Hydroframe (Hes) | MicroVention, Inc. | 2009 | 2 |
| −4 | K103758 | Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10 | MicroVention, Inc. | 2011 | 1 |
| −3 | K111451 | Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V… | MicroVention, Inc. | 2011 | — |
| −2 | K132952 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2013 | 16 |
| −1 | K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) | MicroVention, Inc. | 2016 | 16 |
| 0 (this device) | K161452 | MicroPlex Coil System (MCS) - HyperSoft 3D | MicroVention, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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? (2)
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 |
|---|---|---|---|
| * | K131948 | Microplex Coil System (MCS)Summary page 4…ical Medicine Devices (Office of Device Evaluation, CDRH) PREDICATE DEVICE [807.92(a)(3)] MicroPlex Coil System (MCS) - HyperSoft® 3D (K131948, K153594) DEVICE DESCRIPTION [807.92(a)(4)] HyperSoft® 3D in the MicroPlex Coil System (MCS) consist of an implant coil made o… | 2013 |
| * | K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)Summary page 4…cine Devices (Office of Device Evaluation, CDRH) PREDICATE DEVICE [807.92(a)(3)] MicroPlex Coil System (MCS) - HyperSoft® 3D (K131948, K153594) DEVICE DESCRIPTION [807.92(a)(4)] HyperSoft® 3D in the MicroPlex Coil System (MCS) consist of an implant coil made of platinu… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2019 | Class II | Z-1393-2020 | Process design | The devices may be missing the implant coil. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 16 of the 60 ancestors have a recall of any class.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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) are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS are also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161452: MicroPlex Coil System (MCS) - HyperSoft 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161452
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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