510(k) · Cleared
ClearedNeuroport Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyberkinetics Neurotechnology Systems, Inc. · GZL Electrode, Depth
Cleared on Aug 3, 2007 as substantially equivalent to K042384 (Cyberkinetics, Inc. (Cki), 2005) after a 186-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.
- Decided
- Aug 3, 2007
- Review
- 186 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042384 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK042384 Neuroport Recording Microelectrode Array SystemCyberkinetics, Inc. (Cki) · 2005 · Recalled
- This deviceK070272 Neuroport ElectrodeCyberkinetics Neurotechnology Systems, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK110010 Neuroport Cortical Microelectrode Array SystemBlackrock Microsystems, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K110010Neuroport Cortical Microelectrode Array SystemBlackrock Microsystems, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042384 | Neuroport Recording Microelectrode Array System | Cyberkinetics, Inc. (Cki) | 2005 | 2 |
| 0 (this device) | K070272 | Neuroport Electrode | Cyberkinetics Neurotechnology Systems, Inc. | 2007 | — |
| +1 | K110010 | Neuroport Cortical Microelectrode Array System | Blackrock Microsystems, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K042384 | Neuroport Recording Microelectrode Array SystemSummary page 1…CFR 882.1330, Product Code: GZL, Class II Predicate Device: NeuroPortrm Mieroelectrode Array System (NeuroPort Array) K042384 1.0 Description of Device The NeuroPort Array connects to the NeuroPort System (5 10(k) K042626 and K06052… | 2005 |
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 |
|---|---|---|---|
| K110010 | Neuroport Cortical Microelectrode Array System | 2011 | 0 |
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?
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Neurotechnology Systems, 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/K070272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070272: Neuroport Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070272
Report an extraction error
Are you the manufacturer?
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