510(k) · Cleared
ClearedNeuroport Neural Signal Processing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cyberkinetics, Inc. · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Mar 28, 2006 as substantially equivalent to K042626 (Cyberkinetics, Inc., 2005) after a 29-day review. Its family tree reaches back 1 generation to 2005. 9 later devices descend from it.
- Decided
- Mar 28, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042626 (2005). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK042626 Neuroport Neural Signal Processor (NSP) SystemCyberkinetics, Inc. · 2005
- This deviceK060523 Neuroport Neural Signal Processing SystemCyberkinetics, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK103140 Nicolet Wireless EegCarefusion 209, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 1 of its ownK170441 ElectroTekMobilemedtek · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK162681 Enobio Wireless EEGNeuroelectrics Barcelona S.L.U. · 2017
- Descendant · 2 generations on · 1 of its ownK151600 R-40 EEG AmplifierLifelines, Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK261604 Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio…Neuroelectrics Barcelona S.L.U. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K103140Nicolet Wireless EegCarefusion 209, Inc. · 2011 · cites it directly7descendants
- K170441ElectroTekMobilemedtek · 2017 · 2 generations on1descendant
- K162681Enobio Wireless EEGNeuroelectrics Barcelona S.L.U. · 2017 · 2 generations on1descendant
- K151600R-40 EEG AmplifierLifelines, Ltd. · 2015 · 2 generations on1descendant
- K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042626 | Neuroport Neural Signal Processor (NSP) System | Cyberkinetics, Inc. | 2005 | — |
| 0 (this device) | K060523 | Neuroport Neural Signal Processing System | Cyberkinetics, Inc. | 2006 | — |
| +1 | K103140 | Nicolet Wireless Eeg | Carefusion 209, Inc. | 2011 | 1 |
| +2 | K170441 | ElectroTek | Mobilemedtek | 2017 | 2 |
| +2 | K162681 | Enobio Wireless EEG | Neuroelectrics Barcelona S.L.U. | 2017 | — |
| +2 | K151600 | R-40 EEG Amplifier | Lifelines, Ltd. | 2015 | — |
| +3 | K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | Neuroelectrics Barcelona S.L.U. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2022 | 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 OMC? 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 OMC device
- #1 K251550 NX01 (NX01)score 13.1 · 10 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 |
|---|---|---|---|
| * | K042626 | Neuroport Neural Signal Processor (NSP) SystemSummary page 1…fication Name: Electroencephalograph, CFR 882.1400, Product Code: GWQ, Class I1 Predicate Device: NeuroPort System, 5 10(k) K042626 1.0 Description of Device The NeuroPort System, when connected to the NeuroPort Array Electrode, supports… | 2005 |
What descends from it? (9)
2 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)
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 OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OMC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMC
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMC
No recall names OMC since 2007.
Adverse event reports per year · OMC
2in 2025
MAUDE reports naming product code OMC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 3 | 56 | 0 | 2 |
| 2025 | 3 | 172 | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort 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/K060523 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060523: Neuroport Neural Signal Processing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060523
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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