510(k) · Cleared
Recalled · 2010Neuroport Recording Microelectrode Array System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyberkinetics, Inc. (Cki) · GZL Electrode, Depth
Cleared on Mar 29, 2005 after a 209-day review. The FDA summary names its predicate without a number. 14 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 29, 2005
- Review
- 209 days
- Class
- Class II
- Product code
- GZL
- Recalls
- 2
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK042384 Neuroport Recording Microelectrode Array SystemCyberkinetics, Inc. (Cki) · 2005
- Descendant · cites it directly · 11 of its ownK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006
- Descendant · 2 generations on · 5 of its ownK170959 DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · Recalled
- Descendant · 2 generations on · 5 of its ownK163355 Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth…Ad-Tech Medical Instrument Corporation · 2017 · Recalled
- Descendant · 3 generations on · 2 of its ownK211367 Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021
- Descendant · 3 generations on · 1 of its ownK213170 SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd. · 2023
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K053358Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesAd-Tech Medical Instrument Corp · 2006 · cites it directly11descendants
- K170959DIXI Medical Microdeep Depth ElectrodeDixi Medical · 2017 · 2 generations on5descendants
- K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer…Ad-Tech Medical Instrument Corporation · 2017 · 2 generations on5descendants
- K211367Evo sEEG SystemNeuroone Medical Technologies Corp. · 2021 · 3 generations on2descendants
- K213170SENSOSEEG Depth ElectrodesSensomedical Labs, Ltd. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042384 | Neuroport Recording Microelectrode Array System | Cyberkinetics, Inc. (Cki) | 2005 | — |
| +1 | K053358 | Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth… | Ad-Tech Medical Instrument Corp | 2006 | — |
| +2 | K170959 | DIXI Medical Microdeep Depth Electrode | Dixi Medical | 2017 | 9 |
| +2 | K163355 | Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes… | Ad-Tech Medical Instrument Corporation | 2017 | 5 |
| +3 | K211367 | Evo sEEG System | Neuroone Medical Technologies Corp. | 2021 | — |
| +3 | K213170 | SENSOSEEG Depth Electrodes | Sensomedical Labs, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 GZL? 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 GZL device
- #1 K253970 Wovyn Depth Electrodescore 13.3 · 8 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 |
|---|---|---|---|
| * | — | Ad-Tech Spencer® Depth Electrode Named without a submission number |
What descends from it? (14)
See all 142 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 26, 2010 | Not classified | Z-1619-2010 | Device Design | Component of cranial array may not allow sufficient tightening to maintain inserter position. |
| Feb 4, 2009 | Not classified | Z-1553-2009 | Packaging process control | Sterility of product cannot be assured |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053358 (Ad-Tech Medical Instrument Corp, 2006) has gone furthest, with 11 descendants of its own.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZL
206in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZL
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZL
12in 2025
MAUDE reports naming product code GZL, 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 | 3 | 166 | 0 | 0 |
| 2008 | 0 | — | 3 | 8 |
| 2009 | 1 | — | 2 | 5 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 25 |
| 2014 | 1 | — | 1 | 7 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 4 | 222 | 0 | 3 |
| 2018 | 3 | 58 | 0 | 2 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 24 |
| 2021 | 3 | 262 | 9 | 13 |
| 2022 | 3 | 90 | 0 | 10 |
| 2023 | 3 | 206 | 0 | 30 |
| 2024 | 0 | — | 3 | 16 |
| 2025 | 2 | — | 0 | 12 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The intended use of the Cyberkinetics, Inc. Neuroport Microelectrode Array System is for temporary (<30 days) recording and monitoring of brain electrical activity
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042384 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042384: Neuroport Recording Microelectrode Array System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042384
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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