510(k) · Cleared
ClearedNumen™ Helia 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 May 20, 2026 as substantially equivalent to K242154 (MicroPort NeuroTech (Shanghai) Co., Ltd., 2024) after a 106-day review. Its family tree reaches back 17 generations to 1995.
- Decided
- May 20, 2026
- Review
- 106 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K951256 (1995). 46 ancestors in all, the oldest K860840 (1986). No later device cites it as a predicate yet.
- Root · 17 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 13 generations between
- 3 generations backK203625 Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2021
- 2 generations backK232955 Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024
- 1 generation backK242154 Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024
- This deviceK260351 Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2026
Show all 17 generations
- Root · 17 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 16 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 15 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 14 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 13 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 12 generations backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- 11 generations backK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- 10 generations backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- 9 generations backK102672 Target Detachable CoilBoston Scientific Corp · 2010
- 8 generations backK112385 Traget Detachable CoilStryker Neurovascular · 2011
- 7 generations backK113412 Target Detachable CoilStryker Neurovascular · 2011 · Recalled
- 6 generations backK123377 Target Detachable CoilStryker Neurovascular · 2012
- 5 generations backK153658 Target Detachable CoilsStryker Neurovascular · 2016 · Recalled
- 4 generations backK161429 Target Detachable CoilsStryker Neurovascular · 2016
- 3 generations backK203625 Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2021
- 2 generations backK232955 Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024
- 1 generation backK242154 Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024
- This deviceK260351 Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −16 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −15 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −14 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −13 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −12 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| −11 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| −10 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| −9 | K102672 | Target Detachable Coil | Boston Scientific Corp | 2010 | — |
| −8 | K112385 | Traget Detachable Coil | Stryker Neurovascular | 2011 | — |
| −7 | K113412 | Target Detachable Coil | Stryker Neurovascular | 2011 | 28 |
| −6 | K123377 | Target Detachable Coil | Stryker Neurovascular | 2012 | — |
| −5 | K153658 | Target Detachable Coils | Stryker Neurovascular | 2016 | 28 |
| −4 | K161429 | Target Detachable Coils | Stryker Neurovascular | 2016 | — |
| −3 | K203625 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2021 | — |
| −2 | K232955 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024 | — |
| −1 | K242154 | Numen™ Coil Embolization System; NumenFR™ Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K242154 | Numen™ Coil Embolization System; NumenFR™ Detachment SystemSummary page 5…(KRD) Use Prescription Use Only Legally Marketed Numen™ Coil Embolization System; NumenFR™ Predicate Device Detachment System (K242154) 510(k) Summary K260351 Page 2 o… | 2024 |
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 31 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 9 of the 46 ancestors have a recall of any class.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Helia Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Numen Helia 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 detachable coils in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260351: Numen™ Helia 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/K260351
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026