510(k) · Cleared
ClearedEndoluminal Occlusion System-EOS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artventive Medical Group, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Sep 25, 2015 as substantially equivalent to K133924 (Artventive Medical Group, Inc., 2014) after a 219-day review. Its family tree reaches back 15 generations to 1995. 1 later device descends from it.
- Decided
- Sep 25, 2015
- Review
- 219 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K951256 (1995). 85 ancestors in all, the oldest K860840 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 11 generations between
- 3 generations backK093002 Azur Peripheral Hydrocoil Endovascular Embolization…MicroVention, Inc. · 2009
- 2 generations backK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- 1 generation backK133924 Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc. · 2014
- This deviceK150402 Endoluminal Occlusion System-EOSArtventive Medical Group, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK212057 Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc. · 2022
Show all 15 generations
- Root · 15 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 14 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 13 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 12 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 11 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 10 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 9 generations backK020434 Microplex Coil System (MCS)MicroVention, Inc. · 2002
- 8 generations backK032590 Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 7 generations backK033836 Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2003
- 6 generations backK041551 Modification to: Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2004
- 5 generations backK050954 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2005 · Recalled
- 4 generations backK071939 Hydrocoil Embolic Systems (Hes)MicroVention, Inc. · 2008
- 3 generations backK093002 Azur Peripheral Hydrocoil Endovascular Embolization…MicroVention, Inc. · 2009
- 2 generations backK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- 1 generation backK133924 Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc. · 2014
- This deviceK150402 Endoluminal Occlusion System-EOSArtventive Medical Group, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −14 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −13 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −12 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −11 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −10 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −9 | K020434 | Microplex Coil System (MCS) | MicroVention, Inc. | 2002 | — |
| −8 | K032590 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −7 | K033836 | Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2003 | — |
| −6 | K041551 | Modification to: Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2004 | — |
| −5 | K050954 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2005 | 16 |
| −4 | K071939 | Hydrocoil Embolic Systems (Hes) | MicroVention, Inc. | 2008 | — |
| −3 | 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 | — |
| −1 | K133924 | Endoluminal Occlusion System (Eos) | Artventive Medical Group, Inc. | 2014 | — |
| 0 (this device) | K150402 | Endoluminal Occlusion System-EOS | Artventive Medical Group, Inc. | 2015 | — |
| +1 | K212057 | Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS | Artventive Medical Group, 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 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1994 | 5 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 9 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 6 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K133924 | Endoluminal Occlusion System (Eos)Summary page 5…Group, ArtVentive Medical Group, Inc./EOS / Device Inc./EOS 510(k) Number K150402 K133924 Application / 21 CFR 870.3300 (KRD) 21 CFR 870.3300 (KRD) Product Code FDA Class II… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212057 | Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS | 2022 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 14 of the 85 ancestors have a recall of any class.
- Of its descendants, K212057 (Artventive Medical Group, Inc., 2022) has gone furthest, with 0 descendants of its own.
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. 2015, 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 ArtVentive Endoluminal Occlusion System (EOS) is intended for arterial and venous embolization in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150402: Endoluminal Occlusion System-EOS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150402
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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