510(k) · Cleared
ClearedGDC Ultrasoft Coil
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific, Target · HCG Device, Neurovascular Embolization
Cleared on Aug 11, 2000 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 60 later devices descend from it.
- Decided
- Aug 11, 2000
- Review
- 23 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 0
60 later devices descend from it, 2 citing it directly.
- This deviceK002181 GDC Ultrasoft CoilBoston Scientific, Target · 2000
- Descendant · cites it directly · 58 of its ownK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- Descendant · 2 generations on · 21 of its ownK103008 Inzone Detachment SystemBoston Scientific Corp · 2010
- Descendant · 2 generations on · 16 of its ownK102672 Target Detachable CoilBoston Scientific Corp · 2010
- Descendant · 2 generations on · 15 of its ownK123338 Barricade Embolization Coil SystemBlockade Medical · 2013
- Descendant · 2 generations on · 15 of its ownK112385 Traget Detachable CoilStryker Neurovascular · 2011
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K093142Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010 · cites it directly58descendants
- K103008Inzone Detachment SystemBoston Scientific Corp · 2010 · 2 generations on21descendants
- K102672Target Detachable CoilBoston Scientific Corp · 2010 · 2 generations on16descendants
- K123338Barricade Embolization Coil SystemBlockade Medical · 2013 · 2 generations on15descendants
- K112385Traget Detachable CoilStryker Neurovascular · 2011 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002181 | GDC Ultrasoft Coil | Boston Scientific, Target | 2000 | — |
| +1 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| +2 | K103008 | Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| +2 | K102672 | Target Detachable Coil | Boston Scientific Corp | 2010 | — |
| +2 | K123338 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
| +2 | K112385 | Traget Detachable Coil | Stryker Neurovascular | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (60)
See all 602 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K093142 (Boston Scientific Corp, 2010) has gone furthest, with 58 descendants of its own.
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 | — |
https://510kreport.com/device/K002181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002181: GDC Ultrasoft Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002181
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026