510(k) · Cleared
ClearedAE-120A EEG Head Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Kohden Corporation · OMC Reduced- Montage Standard Electroencephalograph
Cleared on Mar 19, 2019 as substantially equivalent to K170363 (Ceribell, Inc., 2017) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1983. 9 later devices descend from it.
- Decided
- Mar 19, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- OMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K830295 (1983). 4 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 1 generation backK170363 Ceribell Pocket EEG DeviceCeribell, Inc. · 2017
- This deviceK183529 AE-120A EEG Head SetNihon Kohden Corporation · 2019
- Descendant · cites it directly · 4 of its ownK202334 NeuronauteBioserenity Sas · 2020
- Descendant · cites it directly · 3 of its ownK203827 REMIEpitel, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK231366 Neuronaute PlusBioserenity Sas · 2023
- Descendant · 2 generations on · 1 of its ownK230933 REMI Remote EEG Monitoring SystemEpitel, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK223644 Neuronaute with IceCap 2 & IceCap 2 SmallBioserenity · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K202334NeuronauteBioserenity Sas · 2020 · cites it directly4descendants
- K203827REMIEpitel, Inc. · 2021 · cites it directly3descendants
- K231366Neuronaute PlusBioserenity Sas · 2023 · 2 generations on1descendant
- K230933REMI Remote EEG Monitoring SystemEpitel, Inc. · 2023 · 2 generations on1descendant
- K223644Neuronaute with IceCap 2 & IceCap 2 SmallBioserenity · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −1 | K170363 | Ceribell Pocket EEG Device | Ceribell, Inc. | 2017 | — |
| 0 (this device) | K183529 | AE-120A EEG Head Set | Nihon Kohden Corporation | 2019 | — |
| +1 | K202334 | Neuronaute | Bioserenity Sas | 2020 | — |
| +1 | K203827 | REMI | Epitel, Inc. | 2021 | — |
| +2 | K231366 | Neuronaute Plus | Bioserenity Sas | 2023 | — |
| +2 | K230933 | REMI Remote EEG Monitoring System | Epitel, Inc. | 2023 | — |
| +2 | K223644 | Neuronaute with IceCap 2 & IceCap 2 Small | Bioserenity | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 4 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K170363 | Ceribell Pocket EEG DeviceSummary page 5…e AE-120A EEG Head Set is substantially equivalent to the Ceribell Pocket EEG with the Ceribell Instant EEG Headband. Table 1, below, lists the primary predicate device, K170363 (headbox, processing unit, basic software needed to display, store, and archive EEG and allow user-only annotation and marking; d… | 2017 |
| * | K171459 | Ceribell Instant EEG HeadbandSummary page 6…Reduced- Montage Standard Electroencephalograph analyze EEG or automatically detect events). The secondary predicate device, K171459, is intended to cover the cutaneous electrode component of system, which is necessary to achieve the intended use and does not ch… | 2017 |
| † | K131944 | IEEG | 2014 |
| † | K082886 | Zoom-100DC | 2009 |
| † | K171124 | Nihon Kohden Wireless Input Unit WEE-1200 | 2017 |
| † | K120397 | Meb-2300A Neuropack Evoked Potential and Emg Measuring System | 2012 |
What descends from it? (9)
3 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?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 34.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K202334 (Bioserenity Sas, 2020) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K170363.
How does its category compare?
All OMC devicesOMC Reduced- Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 AE-120A EEG Head Set is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a trained medical professional using the previously cleared and validated Nihon Kohden electroencephalograph systems (EEG-1200A series and EEG-9100) to assist in the diagnosis of neurological disorders. The AE-120A EEG Head Set and its associated EEG Software do not provide any diagnostic conclusion or automated alerts of an…
Read the full statement (109 words)
The AE-120A EEG Head Set is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a trained medical professional using the previously cleared and validated Nihon Kohden electroencephalograph systems (EEG-1200A series and EEG-9100) to assist in the diagnosis of neurological disorders. The AE-120A EEG Head Set and its associated EEG Software do not provide any diagnostic conclusion or automated alerts of an adverse clinical event about a patient's condition.
The device is intended for use by trained medical professionals in a medical facility such as a physician’s office, laboratory, or clinic. The device is intended for use on adults (ages 18 and above).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183529 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183529: AE-120A EEG Head Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183529
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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