510(k) · Cleared
Recalled · Class II · 2026InZone Detachment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Neurovascular · HCG Device, Neurovascular Embolization
Cleared on Nov 16, 2021 as substantially equivalent to K160096 (Stryker Neurovascular, 2016) after a 103-day review. Its family tree reaches back 11 generations to 1995. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 16, 2021
- Review
- 103 days
- Class
- Class II
- Product code
- HCG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K951256 (1995). 37 ancestors in all, the oldest K860840 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 7 generations between
- 3 generations backK103008 Inzone Detachment SystemBoston Scientific Corp · 2010
- 2 generations backK120816 Inzone Detachment SystemStryker · 2012
- 1 generation backK160096 InZone Detachment SystemStryker Neurovascular · 2016
- This deviceK212455 InZone Detachment SystemStryker Neurovascular · 2021
- Descendant · cites it directly · 0 of its ownK251832 InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular · 2025
Show all 11 generations
- Root · 11 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 10 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 9 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 8 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 7 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 6 generations backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- 5 generations backK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- 4 generations backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- 3 generations backK103008 Inzone Detachment SystemBoston Scientific Corp · 2010
- 2 generations backK120816 Inzone Detachment SystemStryker · 2012
- 1 generation backK160096 InZone Detachment SystemStryker Neurovascular · 2016
- This deviceK212455 InZone Detachment SystemStryker Neurovascular · 2021
Most influential descendants
Showing 1 of 1 · See all- K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −10 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −9 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −8 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −7 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −6 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| −5 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| −4 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| −3 | K103008 | Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| −2 | K120816 | Inzone Detachment System | Stryker | 2012 | — |
| −1 | K160096 | InZone Detachment System | Stryker Neurovascular | 2016 | — |
| 0 (this device) | K212455 | InZone Detachment System | Stryker Neurovascular | 2021 | — |
| +1 | K251832 | InZone IST Detachment System; IZDS Connecting Cable | Stryker Neurovascular | 2025 | — |
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 |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K160096 | InZone Detachment SystemSummary page 4…ent: Vascular and Neurovascular Embolization Devices (issued 29 Dec 2004). Legally Marketed InZone Detachment System cleared under K160096 on 19 Feb Predicate Device: 2016. 510(k) Summary page 1 of 7… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251832 | InZone IST Detachment System; IZDS Connecting Cable | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2026 | Class II | Z-2552-2026 | Component design/selection | Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 37 ancestors have a recall of any class.
- Of its descendants, K251832 (Stryker Neurovascular, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K160096.
How does its category compare?
All HCG devicesHCG Device, Neurovascular Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The InZone Detachment System is intended for use with all versions of Stryker Neurovascular 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/K212455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212455: 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/K212455
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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