510(k) · Cleared
ClearedTarget Detachable Coils and Inzone Detachment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · HCG Device, Neurovascular Embolization
Cleared on Feb 4, 2010 as substantially equivalent to K002181 (Boston Scientific, Target, 2000) and 4 other predicates after a 122-day review. Its family tree reaches back 7 generations to 1995. 58 later devices descend from it.
- Decided
- Feb 4, 2010
- Review
- 122 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 7 generations to K951256 (1995). 33 ancestors in all, the oldest K860840 (1986). 58 later devices descend from it, 7 citing it directly.
- 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 backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- 1 generation backK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- This deviceK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- Descendant · cites it directly · 21 of its ownK103008 Inzone Detachment SystemBoston Scientific Corp · 2010
- Descendant · cites it directly · 16 of its ownK102672 Target Detachable CoilBoston Scientific Corp · 2010
- Descendant · cites it directly · 15 of its ownK123338 Barricade Embolization Coil SystemBlockade Medical · 2013
- Descendant · cites it directly · 15 of its ownK112385 Traget Detachable CoilStryker Neurovascular · 2011
- Descendant · 2 generations on · 14 of its ownK131475 Barricade Embolization Coil SystemBlockade Medical · 2013
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K103008Inzone Detachment SystemBoston Scientific Corp · 2010 · cites it directly21descendants
- K102672Target Detachable CoilBoston Scientific Corp · 2010 · cites it directly16descendants
- K123338Barricade Embolization Coil SystemBlockade Medical · 2013 · cites it directly15descendants
- K112385Traget Detachable CoilStryker Neurovascular · 2011 · cites it directly15descendants
- K131475Barricade Embolization Coil SystemBlockade Medical · 2013 · 2 generations on14descendants
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 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| −1 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| 0 (this device) | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| +1 | K103008 | Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| +1 | K102672 | Target Detachable Coil | Boston Scientific Corp | 2010 | — |
| +1 | K123338 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
| +1 | K112385 | Traget Detachable Coil | Stryker Neurovascular | 2011 | — |
| +2 | K131475 | Barricade Embolization Coil System | Blockade Medical | 2013 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 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), 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? (5)
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 |
|---|---|---|---|
| * | K002181 | GDC Ultrasoft CoilSummary page 2…eness (cont.) Legally Marketed Predicate Devices: Reference (Clearance Date) Device K002 181 (11 Aug 2000) GDC I10-UltraSofi® Coils (introduction of UltraSo… | 2000 |
| * | K021494 | GDC Power Supply, Model GDC Power Supply: 451007-4Summary page 2…(11 Aug 2000) GDC I10-UltraSofi® Coils (introduction of UltraSoft coils) K02 1494 (6 June 2002) GDC Power Supply and Detachable Coil Connecting Ca… | 2002 |
| * | K031049 | Guglielmi Detachable Coil (GDC)Summary page 2…1494 (6 June 2002) GDC Power Supply and Detachable Coil Connecting Cables K03 1049 (3 June 2003) Clearance of ISAT indication for all GDG devices… | 2003 |
| * | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree CoilSummary page 2…K03 1049 (3 June 2003) Clearance of ISAT indication for all GDG devices K042539 (19 Oct 2004) GDC 360 Detachable Coils (introduction of 360 sha… | 2004 |
| * | K050700 | Matrix Stretch Resistant (SR) CoilsSummary page 2…(19 Oct 2004) GDC 360 Detachable Coils (introduction of 360 shape coils) K050700 (15 April 2005) Matrix 2® De~tachable Coils Device Description: Boston Scientific Corporation's Target Detachable C… | 2005 |
What descends from it? (58)
See all 587 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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 7 of the 33 ancestors have a recall of any class.
- Of its descendants, K103008 (Boston Scientific Corp, 2010) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K002181.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
Target Detachable Coils are indicated for the endovascular embolization of:
* Intracranial aneurysms
• Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
• Arterial and venous embolizations in the peripheral vasculature
The InZone Detachment System is intended for use with all Boston Scientific Detachable Coils in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093142: Target Detachable Coils and Inzone 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/K093142
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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