510(k) · Cleared
ClearedNeuroport Cortical Microelectrode Array System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blackrock Microsystems, Inc. · GZL Electrode, Depth
Cleared on Feb 9, 2011 as substantially equivalent to K070272 (Cyberkinetics Neurotechnology Systems, Inc., 2007) after a 37-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Feb 9, 2011
- Review
- 37 days
- Class
- Class II
- Product code
- GZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K042384 (2005). No later device cites it as a predicate yet.
- Root · 2 generations backK042384 Neuroport Recording Microelectrode Array SystemCyberkinetics, Inc. (Cki) · 2005 · Recalled
- 1 generation backK070272 Neuroport ElectrodeCyberkinetics Neurotechnology Systems, Inc. · 2007
- This deviceK110010 Neuroport Cortical Microelectrode Array SystemBlackrock Microsystems, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K042384 | Neuroport Recording Microelectrode Array System | Cyberkinetics, Inc. (Cki) | 2005 | 2 |
| −1 | K070272 | Neuroport Electrode | Cyberkinetics Neurotechnology Systems, Inc. | 2007 | — |
| 0 (this device) | K110010 | Neuroport Cortical Microelectrode Array System | Blackrock Microsystems, Inc. | 2011 | — |
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 |
|---|---|---|---|
| * | K070272 | Neuroport ElectrodeSummary page 2…Page I of3 5; PREDICATE DEVICES The predicate device NeuroPortTMi Electrode previously cleared August 3, 2007 under K070272. 6&DEVICE DESCRIPTION The Neurolort' ' Electrode (SIROF) detects the electrical activity of cortical neurons during sub-chro… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All GZL devicesGZL Electrode, Depth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Blackrock Neurosystems LLC, Neuroport TM 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/K110010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110010: Neuroport Cortical Microelectrode Array System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110010
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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