510(k) · Cleared
ClearedHydrocoil Embolic Systems (Hes)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroVention, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Jan 11, 2008 as substantially equivalent to K983483 (Cordis Neurovascular, Inc., 1999) and 2 other predicates after a 182-day review. Its family tree reaches back 11 generations to 1995. 23 later devices descend from it.
- Decided
- Jan 11, 2008
- Review
- 182 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K951256 (1995). 48 ancestors in all, the oldest K860840 (1986). 23 later devices descend from it, 6 citing it directly.
- Root · 11 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 7 generations between
- 3 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 2 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 1 generation backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- This deviceK071939 Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008
- Descendant · cites it directly · 12 of its ownK093002 Azur Peripheral Hydrocoil Endovascular Embolization…MicroVention, Inc. · 2009
- Descendant · 2 generations on · 10 of its ownK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- Descendant · 3 generations on · 6 of its ownK133282 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- Descendant · 3 generations on · 5 of its ownK141313 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
- Descendant · cites it directly · 5 of its ownK091882 Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc. · 2009
Show all 11 generations
- Root · 11 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 10 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 9 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 8 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 7 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 6 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 5 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 4 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 3 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 2 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 1 generation backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- This deviceK071939 Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…MicroVention, Inc. · 2009 · cites it directly12descendants
- K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · 2 generations on10descendants
- K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · 3 generations on6descendants
- K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014 · 3 generations on5descendants
- K091882Azur Peripheral Hydrocoil Endovascular Embolization SystemMicroVention, Inc. · 2009 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −10 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −9 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −8 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −7 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −6 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −5 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −4 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −3 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −2 | 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 |
| 0 (this device) | K071939 | Hydrocoil Embolic Systems (Hes) | MicroVention, Inc. | 2008 | — |
| +1 | K093002 | Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35… | MicroVention, Inc. | 2009 | — |
| +2 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| +3 | K133282 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| +3 | K141313 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | 2014 | — |
| +1 | K091882 | Azur Peripheral Hydrocoil Endovascular Embolization System | MicroVention, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 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 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 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 KRD? 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 KRD device
- #1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 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 |
|---|---|---|---|
| * | K983483 | Vascular Occlusion SystemSummary page 2…35) coils is substantially equivalent to the Cordis Vascular Occlusion System that was determined to be substantially equivalent on March 24, 1999 (reference K983483), the MicroVention MicroPlex®Coil System (MCS) and Hydr6Coilr Embolic System (HES) with a Modified Detachment System… | 1999 |
| * | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)Summary page 2…em (MCS) and Hydr6Coilr Embolic System (HES) with a Modified Detachment System that was determined to be substantially equivalent on June 28, 2005 (reference K050954) and the MicroVention MicroPlex®Coil System (MCS) and HydroCoil® Embolic System (HES) with the HES-HC-R (18) and HVO-HC-R (… | 2005 |
| * | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)Summary page 2…roCoil® Embolic System (HES) with the HES-HC-R (18) and HVO-HC-R (18) Coils that was determined to be substantially equivalent on October 22, 2003 (reference K032590).. (7) Technological Characteristics and Substantial Equivalence The HydroCoilo Embolic System (HES) with the HES-HC-PP… | 2003 |
What descends from it? (23)
See all 236 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093002 | Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models… | 2009 | 12 |
| K091882 | Azur Peripheral Hydrocoil Endovascular Embolization System | 2009 | 5 |
| K120630 | Azur Detachable 18 | 2012 | 4 |
| K123384 | Azur CX Detachable 18 | 2012 | 3 |
| K122543 | Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable… | 2012 | 2 |
| K130577 | Azur Pushable 18 & 35 System | 2013 | 1 |
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 10 months on median.
- 8 of the 48 ancestors have a recall of any class.
- Of its descendants, K093002 (MicroVention, Inc., 2009) has gone furthest, with 12 descendants of its own.
- 3 other devices also cite its predicate K983483.
How does its category compare?
All KRD devicesKRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KRD
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRD
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRD
1,572in 2025
MAUDE reports naming product code KRD, 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 | 2 | — | 0 | 21 |
| 2008 | 5 | 84 | 0 | 14 |
| 2009 | 4 | 27 | 0 | 40 |
| 2010 | 3 | 150 | 1 | 61 |
| 2011 | 5 | 36 | 0 | 102 |
| 2012 | 8 | 30 | 0 | 137 |
| 2013 | 11 | 33 | 1 | 244 |
| 2014 | 7 | 134 | 0 | 159 |
| 2015 | 11 | 130 | 0 | 337 |
| 2016 | 4 | 164 | 0 | 437 |
| 2017 | 4 | 89 | 0 | 736 |
| 2018 | 4 | 62 | 0 | 1,066 |
| 2019 | 6 | 178 | 0 | 1,185 |
| 2020 | 4 | 137 | 0 | 1,167 |
| 2021 | 3 | 134 | 0 | 1,444 |
| 2022 | 8 | 175 | 0 | 1,498 |
| 2023 | 2 | — | 1 | 1,371 |
| 2024 | 6 | 70 | 1 | 1,535 |
| 2025 | 9 | 60 | 0 | 1,572 |
| 2026 | 7 | 70 | 1 | — |
What is it indicated for?
The HydroCoil® Embolic System (HES) with the HES-HC-PP (18) and HES-HC-PP (35) coils is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms and other lesions of the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071939 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071939: Hydrocoil Embolic Systems (Hes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071939
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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