510(k) · Cleared
ClearedInzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250
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 Sep 30, 2009 as substantially equivalent to K021494 (Boston Scientific, Target, 2002) after a 30-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Sep 30, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K951256 (1995). 26 ancestors in all, the oldest K860840 (1986). No later device cites it as a predicate yet.
- Root · 6 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 5 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 4 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 3 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 2 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 1 generation backK021494 GDC Power Supply, Model GDC Power Supply: 451007-4Boston Scientific, Target · 2002
- This deviceK092666 Inzone Detachment System, Model M00345100940, Izds Connecting Cable…Boston Scientific Corp · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −5 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −4 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −3 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −2 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −1 | K021494 | GDC Power Supply, Model GDC Power Supply: 451007-4 | Boston Scientific, Target | 2002 | — |
| 0 (this device) | K092666 | Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model… | Boston Scientific Corp | 2009 | — |
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 | 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 |
|---|---|---|---|
| * | K021494 | GDC Power Supply, Model GDC Power Supply: 451007-4Summary page 1…Dec 2004). Legally Marketed Predicate Devices: Reference (Clearance Date) Device K021494 (6 June 2002) GDC® Power Supply and Detachable Coil Connectin… | 2002 |
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 14 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 26 ancestors have a recall of any class.
- 1 other device also cites its predicate K021494.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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/K092666 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092666: Inzone Detachment System, Model M00345100940, Izds Connecting Cable, Model M00345100250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092666
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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