510(k) · Cleared
ClearedModification to: Hydrocoil Embolic System (Hes)
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 7, 2004 as substantially equivalent to K032590 (MicroVention, Inc., 2003) and 2 other predicates after a 28-day review. Its family tree reaches back 9 generations to 1995. 66 later devices descend from it.
- Decided
- Jul 7, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K951256 (1995). 40 ancestors in all, the oldest K860840 (1986). 66 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 5 generations between
- 3 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 2 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 1 generation backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- This deviceK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- Descendant · cites it directly · 65 of its ownK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 36 of its ownK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
- Descendant · 2 generations on · 35 of its ownK082461 Bare Platinum Framing Coil, Model (S)…MicroVention, Inc. · 2008
- Descendant · 3 generations on · 34 of its ownK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
- Descendant · 3 generations on · 27 of its ownK090891 Microplex Coil System-CosmosMicroVention, Inc. · 2009 · Recalled
Show all 9 generations
- Root · 9 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 8 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 7 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 6 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 5 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 4 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 3 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 2 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 1 generation backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- This deviceK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · cites it directly65descendants
- K070656Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007 · 2 generations on36descendants
- K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc. · 2008 · 2 generations on35descendants
- K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008 · 3 generations on34descendants
- K090891Microplex Coil System-CosmosMicroVention, Inc. · 2009 · 3 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −8 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −7 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −6 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −5 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −4 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −3 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −2 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −1 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| 0 (this device) | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| +1 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| +2 | K070656 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2007 | — |
| +2 | K082461 | Bare Platinum Framing Coil, Model (S)… | MicroVention, Inc. | 2008 | — |
| +3 | K080666 | Hydrosoft and Hydrosoft Plus Embolization Coil Systems | MicroVention, Inc. | 2008 | — |
| +3 | K090891 | Microplex Coil System-Cosmos | MicroVention, Inc. | 2009 | 2 |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)Summary page 2…em (HES) is substantially equivalent to the HydroCoil® Embolic System (HES) that was determined to be substantially equivalent on October 22, 2003 (reference K032590) and December 30, 2003 (reference K033836), and to the MatrixTM Stretch Resistant Detachable Coils that were determined to… | 2003 |
| * | K033836 | Hydrocoil Embolic System (Hes)Summary page 2…e HydroCoil® Embolic System (HES) that was determined to be substantially equivalent on October 22, 2003 (reference K032590) and December 30, 2003 (reference K033836), and to the MatrixTM Stretch Resistant Detachable Coils that were determined to be substantially equivalent on May 1… | 2003 |
| * | K031168 | Matrix Stretch Resistant Detachable CoilSummary page 2…03 (reference K033836), and to the MatrixTM Stretch Resistant Detachable Coils that were determined to be substantially equivalent on May 14, 2003 (reference K031168). (7) Technological Characteristics and Substantial Equivalence The modified HydroCoil® Embolic System (HES) is equiva… | 2003 |
What descends from it? (66)
See all 661 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | 2005 | 65 |
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 9 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 7 of the 40 ancestors have a recall of any class.
- Of its descendants, K050954 (MicroVention, Inc., 2005) has gone furthest, with 65 descendants of its own.
- 3 other devices also cite its predicate K032590.
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 HydroCoil® Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
The HES is 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/K041551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041551: Modification to: Hydrocoil Embolic System (Hes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041551
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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