# K042384: Neuroport Recording Microelectrode Array System

- Pathway: 510(k) (Traditional)
- Applicant: Cyberkinetics, Inc. (Cki)
- Decided: Mar 29, 2005 after 209 days
- Product code: GZL (Electrode, Depth)
- Device class: 2
- Regulation: 21 CFR 882.1330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ad-Tech Spencer® Depth Electrode: named in the summary without a submission number

## Most influential descendants
- K053358: Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth Electrodes (2006), 11 descendants of its own
- K170959: DIXI Medical Microdeep Depth Electrode (2017), 5 descendants of its own
- K163355: Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes (2017), 5 descendants of its own
- K211367: Evo sEEG System (2021), 2 descendants of its own
- K213170: SENSOSEEG Depth Electrodes (2023), 1 descendant of its own

## Recalls of this device
- Mar 26, 2010 · Not classified · Z-1619-2010: Component of cranial array may not allow sufficient tightening to maintain inserter position.
- Feb 4, 2009 · Not classified · Z-1553-2009: Sterility of product cannot be assured

## Indications for use
The intended use of the Cyberkinetics, Inc. Neuroport Microelectrode Array System is for temporary (<30 days) recording and monitoring of brain electrical activity

Source page: https://510kreport.com/device/K042384
Methodology: https://510kreport.com/methodology