510(k) · Cleared
ClearedHydrocoil 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 Dec 30, 2003 as substantially equivalent to K032590 (MicroVention, Inc., 2003) and 2 other predicates after a 20-day review. Its family tree reaches back 8 generations to 1995. 67 later devices descend from it.
- Decided
- Dec 30, 2003
- Review
- 20 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K951256 (1995). 37 ancestors in all, the oldest K860840 (1986). 67 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 7 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 6 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 5 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 4 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 3 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 2 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 1 generation backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- This deviceK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- Descendant · cites it directly · 66 of its ownK041551 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 · cites it directly · 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 · 2 generations on · 34 of its ownK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K041551Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004 · cites it directly66descendants
- K050954Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · cites it directly65descendants
- K070656Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007 · cites it directly36descendants
- K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc. · 2008 · 2 generations on35descendants
- K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008 · 2 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −7 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −6 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −5 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −4 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −3 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −2 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −1 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| 0 (this device) | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| +1 | 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 |
| +1 | K070656 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2007 | — |
| +2 | K082461 | Bare Platinum Framing Coil, Model (S)… | MicroVention, Inc. | 2008 | — |
| +2 | K080666 | Hydrosoft and Hydrosoft Plus Embolization Coil Systems | MicroVention, Inc. | 2008 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)Summary page 2…0) coils is substantially equivalent to the HydroCoil® Embolic System (HES) that was determined to be substantially equivalent on October 22, 2003 (reference K032590), the GDC-10 Stretch Resistant Guglielmi Detachable Coil that was determined to be substantially equivalent on Januar… | 2003 |
| * | K993415 | GDC-10 Stretch Resistant Guglielmi Detachable Coil, GDC-10 2-Diameter Stretch Resistant…Summary page 2…(reference K032590), the GDC-10 Stretch Resistant Guglielmi Detachable Coil that was determined to be substantially equivalent on January 21, 2000 (reference K993415) and the Fibered GDC-18 VortX Shape Guglielmi Detachable Coil that was determined to be substantially equivalent on January… | 2000 |
| * | K993418 | Fibered GDC-18 Vortx Shape Guglielmi Detachable CoilSummary page 2…rence K993415) and the Fibered GDC-18 VortX Shape Guglielmi Detachable Coil that was determined to be substantially equivalent on January 21, 2000 (reference K993418). (7) Technological Characteristics and Substantial Equivalence The HydroCoi/® Embolic System (HES) with the HES-HC-S… | 2000 |
What descends from it? (67)
See all 673 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 8 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 5 of the 37 ancestors have a recall of any class.
- Of its descendants, K041551 (MicroVention, Inc., 2004) has gone furthest, with 66 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/K033836 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033836: Hydrocoil Embolic System (Hes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033836
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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