510(k) · Cleared
ClearedHydrosoft and Hydrosoft Plus Embolization Coil Systems
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 11, 2008 as substantially equivalent to K070656 (MicroVention, Inc., 2007) after a 123-day review. Its family tree reaches back 12 generations to 1995. 34 later devices descend from it.
- Decided
- Jul 11, 2008
- Review
- 123 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K951256 (1995). 43 ancestors in all, the oldest K860840 (1986). 34 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 8 generations between
- 3 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 2 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 1 generation backK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
- This deviceK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
- Descendant · cites it directly · 21 of its ownK112226 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2011
- Descendant · 2 generations on · 20 of its ownK113457 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2011
- Descendant · 2 generations on · 19 of its ownK120908 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2012
- Descendant · 3 generations on · 15 of its ownK123338 Barricade Embolization Coil SystemBlockade Medical · 2013
- Descendant · 4 generations on · 14 of its ownK131475 Barricade Embolization Coil SystemBlockade Medical · 2013
Show all 12 generations
- Root · 12 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 11 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 10 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 9 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 8 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 7 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 6 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 5 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 4 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 3 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 2 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 1 generation backK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
- This deviceK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K112226Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2011 · cites it directly21descendants
- K113457Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2011 · 2 generations on20descendants
- K120908Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2012 · 2 generations on19descendants
- K123338Barricade Embolization Coil SystemBlockade Medical · 2013 · 3 generations on15descendants
- K131475Barricade Embolization Coil SystemBlockade Medical · 2013 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −11 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −10 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −9 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −8 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −7 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −6 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −5 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −4 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −3 | 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 |
| −1 | K070656 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2007 | — |
| 0 (this device) | K080666 | Hydrosoft and Hydrosoft Plus Embolization Coil Systems | MicroVention, Inc. | 2008 | — |
| +1 | K112226 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2011 | — |
| +2 | K113457 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2011 | — |
| +2 | K120908 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2012 | — |
| +3 | K123338 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
| +4 | K131475 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 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? (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 |
|---|---|---|---|
| * | K070656 | Hydrocoil Embolic System (Hes)Summary page 1…Aliso Viejo, CA 92656 Contact: Kevin E. Daly Predicate HydroCoil® Embolic System with (HES) with the HES-HC-HS (10) Devices: Coils (K070656) Device Description: The HydroSoft® and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils are platinum emboliza… | 2007 |
What descends from it? (34)
See all 343 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 13 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 8 of the 43 ancestors have a recall of any class.
- Of its descendants, K112226 (MicroVention, Inc., 2011) has gone furthest, with 21 descendants of its own.
- 2 other devices also cite its predicate K070656.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 HydroSoft and HydroSoft Plus Embolization Coil Systems with HES-HC-HS (10) Coils are intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula.
The HydroSoft and HydroSoft Plus Embolization Coils Systems also are 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 embolization in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080666 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080666: Hydrosoft and Hydrosoft Plus Embolization Coil Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080666
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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