510(k) · Cleared
ClearedMicroplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink Syringe Kit
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 Sep 6, 2002 as substantially equivalent to K012145 (MicroVention, Inc., 2001) and 3 other predicates after an 18-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Sep 6, 2002
- Review
- 18 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K951256 (1995). 32 ancestors in all, the oldest K860840 (1986). No later device cites it as a predicate yet.
- Root · 7 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 6 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 5 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 4 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 3 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 2 generations backK012145 Microplex Coil SystemMicroVention, Inc. · 2001
- 1 generation backK021914 Microplex Coil Systems (MCS)MicroVention, Inc. · 2002
- This deviceK022735 Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with…MicroVention, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −6 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −5 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −4 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −3 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −2 | K012145 | Microplex Coil System | MicroVention, Inc. | 2001 | — |
| −1 | K021914 | Microplex Coil Systems (MCS) | MicroVention, Inc. | 2002 | — |
| 0 (this device) | 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 | 4 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 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? (4)
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…one or more complex coils. The MCS-CC-2D, MCS-CC-lD, MCS-HC-R and MCS- HC-S platinum coils were determined to be substantially equivalent on October 29, 2001 (reference K012145). The MCS-HC-SX platinum coils were determined to be substantially equivalent on July 9, 2002 (reference K021914). The complex an… | 2001 |
| * | K021914 | Microplex Coil Systems (MCS)Summary page 2…substantially equivalent on October 29, 2001 (reference K012145). The MCS-HC-SX platinum coils were determined to be substantially equivalent on July 9, 2002 (reference K021914). The complex and helical coils are provided in a number of diameters and lengths to meet the needs of the physician. The MCS-HC… | 2002 |
| * | K020434 | Microplex Coil System (MCS)Summary page 2…has been established by placement of one or more MCS platinum complex coils. The MCS-HCP coils were determined to be substantially equivalent on July 29, 2002 (reference K020434) and were originally included as part of the MicroPlex Coil System (MCS). In order to differentiate the platinudpolymer coils fro… | 2002 |
| * | K875196 | Disposable Coronary Control Syringe 12CCSummary page 2…2001) Microvention MicroPlex Coil System (MCS) - KO21914 (July 9, 2002) Microvention MicroPlex Coil System (MCS) - KO20434 (July 29,2002) Merit Medical Piston Syringe - K875196 (February 11, 1988) Technological Characteristics and Substantial Equivalence The MicroPlex Coil System (MCS) and Hydrocoil Emb… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 months on median.
- 4 of the 32 ancestors have a recall of any class.
- 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) and Hydrocoil Embolic System (HES) with the HydroLink Syringe Kit are 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. The MCS and HES are also intended for embolization of other neuro-vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae and for arterial and venous embolizations in the peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022735 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022735: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink Syringe Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022735
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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