510(k) · Cleared
ClearedInzone 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 Dec 10, 2010 as substantially equivalent to K093142 (Boston Scientific Corp, 2010) after a 59-day review. Its family tree reaches back 8 generations to 1995. 21 later devices descend from it.
- Decided
- Dec 10, 2010
- Review
- 59 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K951256 (1995). 34 ancestors in all, the oldest K860840 (1986). 21 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 7 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 6 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 5 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 4 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 3 generations backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- 2 generations backK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- 1 generation backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- This deviceK103008 Inzone Detachment SystemBoston Scientific Corp · 2010
- Descendant · cites it directly · 10 of its ownK123803 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- Descendant · cites it directly · 9 of its ownK120816 Inzone Detachment SystemStryker · 2012
- Descendant · 2 generations on · 8 of its ownK160096 InZone Detachment SystemStryker Neurovascular · 2016
- Descendant · 2 generations on · 6 of its ownK133282 Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013
- Descendant · 2 generations on · 5 of its ownK141313 Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · cites it directly10descendants
- K120816Inzone Detachment SystemStryker · 2012 · cites it directly9descendants
- K160096InZone Detachment SystemStryker Neurovascular · 2016 · 2 generations on8descendants
- K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation · 2013 · 2 generations on6descendants
- K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation · 2014 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −7 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −6 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −5 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −4 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −3 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| −2 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| −1 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| 0 (this device) | K103008 | Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| +1 | K123803 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| +1 | K120816 | Inzone Detachment System | Stryker | 2012 | — |
| +2 | K160096 | InZone Detachment System | Stryker Neurovascular | 2016 | — |
| +2 | K133282 | Reverse Medical Micro Vascular Plug (MVP) System | Reverse Medical Corporation | 2013 | — |
| +2 | K141313 | Reverse Medical Micro Vascular Plug System | Reverse Medical Corporation | 2014 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K093142 | Target Detachable Coils and Inzone Detachment SystemSummary page 1…ed 29 Dec 2004). Legally Marketed Predicate Devices: Reference (Clearance Date) Device K093 142 (4 Feb 2010) Target Detachable Coils and InZone Detachment Syste… | 2010 |
| † | K092666 | Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250 | 2009 |
What descends from it? (21)
See all 212 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 34 ancestors have a recall of any class.
- Of its descendants, K123803 (Reverse Medical Corporation, 2013) has gone furthest, with 10 descendants of its own.
- 6 other devices also cite its predicate K093142.
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?
Boston Scientific's InZoneTM Detachment System is intended for use with all versions of BSC 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/K103008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103008: 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/K103008
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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