510(k) · Cleared
ClearedNumen Coil Embolization System; NumenFR Detachment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroPort NeuroTech (Shanghai) Co., Ltd. · HCG Device, Neurovascular Embolization
Cleared on Sep 1, 2021 as substantially equivalent to K161429 (Stryker Neurovascular, 2016) and 1 other predicate after a 264-day review. Its family tree reaches back 14 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 1, 2021
- Review
- 264 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K951256 (1995). 43 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 backK123377 Target Detachable CoilStryker Neurovascular · 2012
- 2 generations backK153658 Target Detachable CoilsStryker Neurovascular · 2016 · Recalled
- 1 generation backK161429 Target Detachable CoilsStryker Neurovascular · 2016
- This deviceK203625 Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK232955 Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK242154 Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK260351 Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2026
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 backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- 8 generations backK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- 7 generations backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- 6 generations backK102672 Target Detachable CoilBoston Scientific Corp · 2010
- 5 generations backK112385 Traget Detachable CoilStryker Neurovascular · 2011
- 4 generations backK113412 Target Detachable CoilStryker Neurovascular · 2011 · Recalled
- 3 generations backK123377 Target Detachable CoilStryker Neurovascular · 2012
- 2 generations backK153658 Target Detachable CoilsStryker Neurovascular · 2016 · Recalled
- 1 generation backK161429 Target Detachable CoilsStryker Neurovascular · 2016
- This deviceK203625 Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024 · cites it directly2descendants
- K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024 · 2 generations on1descendant
- K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2026 · 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 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| −8 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| −7 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| −6 | K102672 | Target Detachable Coil | Boston Scientific Corp | 2010 | — |
| −5 | K112385 | Traget Detachable Coil | Stryker Neurovascular | 2011 | — |
| −4 | K113412 | Target Detachable Coil | Stryker Neurovascular | 2011 | 28 |
| −3 | K123377 | Target Detachable Coil | Stryker Neurovascular | 2012 | — |
| −2 | K153658 | Target Detachable Coils | Stryker Neurovascular | 2016 | 28 |
| −1 | K161429 | Target Detachable Coils | Stryker Neurovascular | 2016 | — |
| 0 (this device) | K203625 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2021 | — |
| +1 | K232955 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024 | — |
| +2 | K242154 | Numen™ Coil Embolization System; NumenFR™ Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024 | — |
| +3 | K260351 | Numen™ Helia Coil Embolization System; NumenFR™ Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2026 | — |
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 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K161429 | Target Detachable CoilsSummary page 4…Cardiovascular (KRD) Use Prescription Use Only Predicate devices: Target® Detachable Coils (K161429), InZone Detachment System (K160096) Legally Marketed Predicate Devices Reference devices:… | 2016 |
| * | K160096 | InZone Detachment SystemSummary page 4…se Only Predicate devices: Target® Detachable Coils (K161429), InZone Detachment System (K160096) Legally Marketed Predicate Devices Reference devices: Axium™ Detachable Coil System, K15144… | 2016 |
| † | K151447 | Axium Detachable Coil System | 2015 |
| † | K143218 | Penumbra Smart Coil | 2015 |
| † | K132952 | Microplex Coil System (MCS), Hydrocoil Embolic System (Hes) | 2013 |
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 |
|---|---|---|---|
| K232955 | Numen Coil Embolization System; NumenFR Detachment System | 2024 | 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 26 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 9 of the 43 ancestors have a recall of any class.
- Of its descendants, K232955 (MicroPort NeuroTech (Shanghai) Co., Ltd., 2024) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K161429.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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?
Numen™ Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Numen™ Coil Embolization System is indicated for endovascular embolization of:
- Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- Arterial and venous embolizations in the peripheral vasculature
NumenFR™ Detachment System is intended for use with MicroPort NeuroTech Numen™ Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203625: Numen Coil Embolization System; NumenFR Detachment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203625
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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