510(k) · Cleared
ClearedHydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
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 Apr 22, 2010 as substantially equivalent to K090357 (MicroVention, Inc., 2009) after a 64-day review. Its family tree reaches back 14 generations to 1995. 9 later devices descend from it.
- Decided
- Apr 22, 2010
- Review
- 64 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K951256 (1995). 46 ancestors in all, the oldest K860840 (1986). 9 later devices descend from it, 4 citing it directly.
- Root · 14 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 10 generations between
- 3 generations backK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
- 2 generations backK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
- 1 generation backK090357 Hydroframe (Hes)MicroVention, Inc. · 2009 · Recalled
- This deviceK100454 Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V…MicroVention, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK123384 Azur CX Detachable 18MicroVention, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK132952 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK162524 AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK153594 MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK223050 AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035…MicroVention, Inc. · 2022
Show all 14 generations
- Root · 14 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 13 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 12 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 11 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 10 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 9 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 8 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 7 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 6 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 5 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 4 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 3 generations backK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
- 2 generations backK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
- 1 generation backK090357 Hydroframe (Hes)MicroVention, Inc. · 2009 · Recalled
- This deviceK100454 Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V…MicroVention, Inc. · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K123384Azur CX Detachable 18MicroVention, Inc. · 2012 · cites it directly3descendants
- K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2013 · cites it directly2descendants
- K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc. · 2017 · 2 generations on1descendant
- K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc. · 2016 · 2 generations on1descendant
- K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −13 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −12 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −11 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −10 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −9 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −8 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −7 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −6 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −5 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| −4 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| −3 | K070656 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2007 | — |
| −2 | K080666 | Hydrosoft and Hydrosoft Plus Embolization Coil Systems | MicroVention, Inc. | 2008 | — |
| −1 | K090357 | Hydroframe (Hes) | MicroVention, Inc. | 2009 | 2 |
| 0 (this device) | K100454 | Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V… | MicroVention, Inc. | 2010 | — |
| +1 | K123384 | Azur CX Detachable 18 | MicroVention, Inc. | 2012 | — |
| +1 | K132952 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2013 | 16 |
| +2 | K162524 | AZUR CX Detachable 18 Peripheral Coil System | MicroVention, Inc. | 2017 | — |
| +2 | K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) | MicroVention, Inc. | 2016 | 16 |
| +2 | K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050… | MicroVention, Inc. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K090357 | Hydroframe (Hes)Summary page 1…, California 92780 U.S.A. Contact: Laraine F'angelina Predicate Device: HydroCoil Embolic System, HydroFrame (K090357) Device Description: The HydroFrame coils consist of implant coil made of platinum alloy with… | 2009 |
What descends from it? (9)
4 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 15 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 9 of the 46 ancestors have a recall of any class.
- Of its descendants, K123384 (MicroVention, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K090357.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 HydroCoil Embolic System (HES) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and artiovenous fistula. 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 embolization in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100454: Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100454
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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