# K212455: InZone Detachment System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Neurovascular
- Decided: Nov 16, 2021 after 103 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K951256 (1995). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160096: InZone Detachment System, Stryker Neurovascular (2016) Summary page 4.

## Most influential descendants
- K251832: InZone IST Detachment System; IZDS Connecting Cable (2025), 0 descendants of its own

## Recalls of this device
- Apr 6, 2026 · Class II · Z-2552-2026: 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 c

## Indications for use
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.

Source page: https://510kreport.com/device/K212455
Methodology: https://510kreport.com/methodology