510(k) · Cleared
ClearedMicroplex Coil System- Cosmos
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 Nov 18, 2010 as substantially equivalent to K093358 (MicroVention, Inc., 2010) and 1 other predicate after a 90-day review. Its family tree reaches back 14 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 18, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K951256 (1995). 45 ancestors in all, the oldest K860840 (1986). 3 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 10 generations between
- 3 generations backK082461 Bare Platinum Framing Coil, Model (S)…MicroVention, Inc. · 2008
- 2 generations backK090891 Microplex Coil System-CosmosMicroVention, Inc. · 2009 · Recalled
- 1 generation backK093358 Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V…MicroVention, Inc. · 2010
- This deviceK102365 Microplex Coil System- CosmosMicroVention, Inc. · 2010
- 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 ownK153594 MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 0 of its ownK161452 MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc. · 2016 · Recalled
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 backK082461 Bare Platinum Framing Coil, Model (S)…MicroVention, Inc. · 2008
- 2 generations backK090891 Microplex Coil System-CosmosMicroVention, Inc. · 2009 · Recalled
- 1 generation backK093358 Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V…MicroVention, Inc. · 2010
- This deviceK102365 Microplex Coil System- CosmosMicroVention, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc. · 2013 · cites it directly2descendants
- K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc. · 2016 · 2 generations on1descendant
- K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc. · 2016 · 3 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 | K082461 | Bare Platinum Framing Coil, Model (S)… | MicroVention, Inc. | 2008 | — |
| −2 | K090891 | Microplex Coil System-Cosmos | MicroVention, Inc. | 2009 | 2 |
| −1 | K093358 | Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-V | MicroVention, Inc. | 2010 | — |
| 0 (this device) | K102365 | Microplex Coil System- Cosmos | MicroVention, Inc. | 2010 | — |
| +1 | K132952 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | MicroVention, Inc. | 2013 | 16 |
| +2 | K153594 | MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) | MicroVention, Inc. | 2016 | 16 |
| +3 | K161452 | MicroPlex Coil System (MCS) - HyperSoft 3D | MicroVention, Inc. | 2016 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 2 | 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? (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 |
|---|---|---|---|
| * | K093358 | Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-VSummary page 1…Tustin, California 92780 U.S.A. Contact: Laraine Pangelina Predicate Device: MicroPlex Coil System (MCS) - Cosmos 18 (K093358, K(090891) Device Description: The Cosmos coils consist of an implant coil made of platinum alloy. The coils are designed in 3D… | 2010 |
| * | K090891 | Microplex Coil System-CosmosSummary page 1…Tustin, California 92780 U.S.A. Contact: Laraine Pangelina Predicate Device: MicroPlex Coil System (MCS) - Cosmos 18 (K093358, K(090891) Device Description: The Cosmos coils consist of an implant coil made of platinum alloy. The coils are designed in 3D spherical… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132952 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | 2013 | 2 |
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 10 months on median.
- 9 of the 45 ancestors have a recall of any class.
- Of its descendants, K132952 (MicroVention, Inc., 2013) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K093358.
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. 2010, 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 MicroPlex Coil System is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct bloodflow, 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/K102365 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102365: Microplex Coil System- Cosmos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102365
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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