510(k) · Cleared
ClearedMicroplex Coil Systems (MCS)
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 Jul 9, 2002 as substantially equivalent to K012145 (MicroVention, Inc., 2001) after a 28-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- Jul 9, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K951256 (1995). 27 ancestors in all, the oldest K860840 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 5 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 4 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 3 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 2 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 1 generation backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- This deviceK021914 Microplex Coil Systems (MCS)MicroVention, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK022735 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with…MicroVention, Inc. · 2002
Most influential descendants
Showing 1 of 1 · See all- K022735Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink…MicroVention, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −5 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −4 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −3 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −2 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −1 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| 0 (this device) | K021914 | Microplex Coil Systems (MCS) | MicroVention, Inc. | 2002 | — |
| +1 | K022735 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the… | MicroVention, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K012145 | Microplex Coil SystemSummary page 2…helical coil is substantially equivalent to the MicroPlex Coil System (MCS) that was determined to be substantially equivalent on October 29,2001 (reference K012145). (7) Technological Characteristics and Substantial Equivalence The MicroPlex Coil System (MCS) with the MCS-HC-SX helical… | 2001 |
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 |
|---|---|---|---|
| K022735 | Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink… | 2002 | 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 7 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 2 of the 27 ancestors have a recall of any class.
- Of its descendants, K022735 (MicroVention, Inc., 2002) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K012145.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 MicroPlex Coil System (MCS) is intended for embolization of those intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques or inoperable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021914 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021914: Microplex Coil Systems (MCS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021914
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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