510(k) · Cleared
ClearedNEBA® Compact EEG2R Mobile Headset
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neba Health, LLC · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Mar 2, 2023 as substantially equivalent to K203827 (Epitel, Inc., 2021) and 1 other predicate after an 87-day review. Its family tree reaches back 4 generations to 1983.
- Decided
- Mar 2, 2023
- Review
- 87 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K830295 (1983). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 3 generations backK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- 2 generations backK183529 AE-120A EEG Head SetNihon Kohden Corporation · 2019
- 1 generation backK203827 REMIEpitel, Inc. · 2021
- This deviceK223628 NEBA® Compact EEG2R Mobile HeadsetNeba Health, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −3 | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| −2 | K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019 | — |
| −1 | K203827 | REMI | Epitel, Inc. | 2021 | — |
| 0 (this device) | K223628 | NEBA® Compact EEG2R Mobile Headset | Neba Health, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K203827 | REMISummary page 4…rology; Diagnostic Devices Predicate and reference devices Predicate Type 510K Number Device Manufacturer Primary Predicate K203827 REMI Epitel, Inc. Secondary Predicate K183529 AE-120A EEG Headset Nihon Kohden… | 2021 |
| * | K183529 | AE-120A EEG Head SetSummary page 4…510K Number Device Manufacturer Primary Predicate K203827 REMI Epitel, Inc. Secondary Predicate K183529 AE-120A EEG Headset Nihon Kohden… | 2019 |
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 40 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K203827.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 NEBA® Compact EEG 2R Mobile Headset (NEBA Headset) is intended to capture, amplify, and wirelessly transmit electrical brain activity for review by a trained medical professional using the CEEG2R recording software. The NEBA Headset comprises an electrode positioning system for placing single-use disposable electrodes on the head (Vermed® A10005, ANSI/AAMI EC12 compliant silver/silver-chloride (Ag/AgCl) electrodes). Contained within the headset is a…
Read the full statement (166 words)
The NEBA® Compact EEG 2R Mobile Headset (NEBA Headset) is intended to capture, amplify, and wirelessly transmit electrical brain activity for review by a trained medical professional using the CEEG2R recording software.
The NEBA Headset comprises an electrode positioning system for placing single-use disposable electrodes on the head (Vermed® A10005, ANSI/AAMI EC12 compliant silver/silver-chloride (Ag/AgCl) electrodes).
Contained within the headset is a wireless EEG amplifier module.
The NEBA Headset and its associated software do not provide any diagnostic conclusion or automated alerts of any clinical event about a patient's condition.
The NEBA Headset transmits electrophysiological signals from the electrodes to a CEEG 2R IEC/UL 60950-1 safety compliant computer running the NEBA CEEG 2R recording software.
The system supports six electrode locations (CZ, left ocular, right ocular, left ear, right ear, and ground) on four flat flexible leads and one plastic tab (the latter to support the CZ electrode).
The CEEG2 Headset is intended for use in clinical settings in individuals six years of age and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223628 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223628: NEBA® Compact EEG2R Mobile Headset.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223628
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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