510(k) · Cleared
Recalled · Class II · 2019Hydroframe (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 Apr 10, 2009 as substantially equivalent to K082461 (MicroVention, Inc., 2008) and 1 other predicate after a 57-day review. Its family tree reaches back 13 generations to 1995. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 10, 2009
- Review
- 57 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 13 generations to K951256 (1995). 45 ancestors in all, the oldest K860840 (1986). 14 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 9 generations between
- 3 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 2 generations backK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
- 1 generation backK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
- This deviceK090357 Hydroframe (Hes)MicroVention, Inc. · 2009
- Descendant · cites it directly · 9 of its ownK100454 Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V…MicroVention, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK103758 Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 4 of its ownK111451 Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V…MicroVention, Inc. · 2011
- Descendant · 2 generations on · 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
Show all 13 generations
- Root · 13 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 12 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 11 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 10 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 9 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 8 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 7 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 6 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 5 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 4 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 3 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 2 generations backK070656 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2007
- 1 generation backK080666 Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc. · 2008
- This deviceK090357 Hydroframe (Hes)MicroVention, Inc. · 2009
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K100454Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V…MicroVention, Inc. · 2010 · cites it directly9descendants
- K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc. · 2011 · cites it directly7descendants
- K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…MicroVention, Inc. · 2011 · 2 generations on4descendants
- K123384Azur CX Detachable 18MicroVention, Inc. · 2012 · 2 generations on3descendants
- K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2013 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −12 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −11 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −10 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −9 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −8 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −7 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −6 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −5 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −4 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| −3 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| −2 | K070656 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2007 | — |
| −1 | K080666 | Hydrosoft and Hydrosoft Plus Embolization Coil Systems | MicroVention, Inc. | 2008 | — |
| 0 (this device) | K090357 | Hydroframe (Hes) | MicroVention, Inc. | 2009 | — |
| +1 | K100454 | Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V… | MicroVention, Inc. | 2010 | — |
| +1 | K103758 | Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10 | MicroVention, Inc. | 2011 | 1 |
| +2 | K111451 | Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V… | MicroVention, Inc. | 2011 | — |
| +2 | K123384 | Azur CX Detachable 18 | MicroVention, Inc. | 2012 | — |
| +1 | K132952 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2013 | 16 |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 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? (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 |
|---|---|---|---|
| * | K082461 | Bare Platinum Framing Coil, Model (S)…Summary page 1…flori n.truuvert~mi crovention .corn Predicate Device: 51 0(k) Description Clearance Date K082461IMicroVention, Bare Platinum Framing Coils Oct 2, 2008 K080666 MicroVention, HydroSofi (HES)… | 2008 |
| * | K080666 | Hydrosoft and Hydrosoft Plus Embolization Coil SystemsSummary page 1…Clearance Date K082461IMicroVention, Bare Platinum Framing Coils Oct 2, 2008 K080666 MicroVention, HydroSofi (HES) July 11, 2008 Device Description The HydroFrame coils consist of implant… | 2008 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100454 | Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V… | 2010 | 9 |
| K103758 | Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10 | 2011 | 7 |
| K132952 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | 2013 | 2 |
| K161367 | HydroCoil Embolic System (HES) | 2016 | 0 |
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-1403-2020 | Process design | The devices may be missing the implant coil. |
| Nov 22, 2019 | Class II | Z-1402-2020 | 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 14 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 8 of the 45 ancestors have a recall of any class.
- Of its descendants, K100454 (MicroVention, Inc., 2010) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K082461.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 HydroFrame 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/K090357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090357: Hydroframe (Hes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090357
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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