510(k) · Cleared
ClearedInZone 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 Feb 19, 2016 as substantially equivalent to K120816 (Stryker, 2012) after a 31-day review. Its family tree reaches back 10 generations to 1995. 8 later devices descend from it.
- Decided
- Feb 19, 2016
- Review
- 31 days
- Class
- Class II
- Product code
- HCG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K951256 (1995). 36 ancestors in all, the oldest K860840 (1986). 8 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 6 generations between
- 3 generations backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- 2 generations backK103008 Inzone Detachment SystemBoston Scientific Corp · 2010
- 1 generation backK120816 Inzone Detachment SystemStryker · 2012
- This deviceK160096 InZone Detachment SystemStryker Neurovascular · 2016
- Descendant · cites it directly · 3 of its ownK203625 Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK232955 Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK242154 Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK212455 InZone Detachment SystemStryker Neurovascular · 2021 · Recalled
- Descendant · cites it directly · 1 of its ownK192068 i-ED COILKaneka Pharma America, LLC · 2020
Show all 10 generations
- Root · 10 generations backK951256 Detachable Platinum Coil (Guglielmi Detachable Coil, GDC)Target Therapeutics · 1995
- 9 generations backK960705 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 8 generations backK962503 Guglielmi Detachable CoilTarget Therapeutics · 1996
- 7 generations backK971395 Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type…Target Therapeutics · 1997
- 6 generations backK991139 Guglielmi Detachable (GDC)Boston Scientific, Target · 1999
- 5 generations backK042539 GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18…Boston Scientific Corp · 2004 · Recalled
- 4 generations backK050700 Matrix Stretch Resistant (SR) CoilsBoston Scientific Corp · 2005 · Recalled
- 3 generations backK093142 Target Detachable Coils and Inzone Detachment SystemBoston Scientific Corp · 2010
- 2 generations backK103008 Inzone Detachment SystemBoston Scientific Corp · 2010
- 1 generation backK120816 Inzone Detachment SystemStryker · 2012
- This deviceK160096 InZone Detachment SystemStryker Neurovascular · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2021 · cites it directly3descendants
- K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024 · 2 generations on2descendants
- K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd. · 2024 · 3 generations on1descendant
- K212455InZone Detachment SystemStryker Neurovascular · 2021 · cites it directly1descendant
- K192068i-ED COILKaneka Pharma America, LLC · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −9 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −8 | K962503 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| −7 | K971395 | Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein… | Target Therapeutics | 1997 | — |
| −6 | K991139 | Guglielmi Detachable (GDC) | Boston Scientific, Target | 1999 | — |
| −5 | K042539 | GDC-10 360 Degree Coil SR; GDC-10 360 Degree Soft Coil SR; GDC-18 360 Degree… | Boston Scientific Corp | 2004 | 2 |
| −4 | K050700 | Matrix Stretch Resistant (SR) Coils | Boston Scientific Corp | 2005 | 1 |
| −3 | K093142 | Target Detachable Coils and Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| −2 | K103008 | Inzone Detachment System | Boston Scientific Corp | 2010 | — |
| −1 | K120816 | Inzone Detachment System | Stryker | 2012 | — |
| 0 (this device) | K160096 | InZone Detachment System | Stryker Neurovascular | 2016 | — |
| +1 | K203625 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2021 | — |
| +2 | K232955 | Numen Coil Embolization System; NumenFR Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024 | — |
| +3 | K242154 | Numen™ Coil Embolization System; NumenFR™ Detachment System | MicroPort NeuroTech (Shanghai) Co., Ltd. | 2024 | — |
| +1 | K212455 | InZone Detachment System | Stryker Neurovascular | 2021 | 1 |
| +1 | K192068 | i-ED COIL | Kaneka Pharma America, LLC | 2020 | — |
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 |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 3 | 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 |
|---|---|---|---|
| * | K120816 | Inzone Detachment SystemSummary page 4…004). Legally Marketed Predicate Devices: Reference (Clearance Date) Device K120816 (17 APR 2012) InZone Detachment System Summary of Safety and Effectiveness page 1 of 7 =… | 2012 |
What descends from it? (8)
3 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 21 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 36 ancestors have a recall of any class.
- Of its descendants, K203625 (MicroPort NeuroTech (Shanghai) Co., Ltd., 2021) has gone furthest, with 3 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. 2016, 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/K160096 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160096: InZone Detachment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160096
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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