FDA product code OMC: Reduced- Montage Standard Electroencephalograph
OMC is the FDA product code for reduced- montage standard electroencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel. FDA has cleared 29 510(k) submissions under OMC, 10 in the last five years, from 21 different applicants. The average 510(k) review took 141 days (median 90); 133 days on average over the last three years.
Definition
Acquire, display, store, and archive electroencephalographic signals from the brain using a user-specified and/or sponsor-specified locations with a reduced array (i.e. less than < 16) of electrodes
Classification
| Field | Value |
|---|---|
| Device name | Reduced- Montage Standard Electroencephalograph |
| Device class | Class II |
| Regulation | 21 CFR 882.1400 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OMC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 91 |
| 2019 | 1 | 90 |
| 2020 | 1 | 279 |
| 2021 | 1 | 90 |
| 2022 | 1 | 146 |
| 2023 | 2 | 88 |
| 2024 | 3 | 161 |
| 2025 | 3 | 150 |
| 2026 | 1 | 89 |
Compare with all 510(k) review times · Search every OMC clearance
Top OMC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Brain Monitoring, Inc. | 3 | 2015-10-30 |
| Cleveland Medical Devices, Inc. | 3 | 2002-02-19 |
| Ceribell, Inc. | 2 | 2026-06-30 |
| Forest Devices, Inc. | 2 | 2025-09-03 |
| Epitel, Inc. | 2 | 2023-06-30 |
16 more applicants have OMC clearances. See the full list in Caduvo.
Most recent OMC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261101 | Ceribell, Inc. | Ceribell Monitor | 2026-06-30 | 89 |
| K251550 | Naox Technologies Sas | NX01 (NX01) | 2025-11-25 | 188 |
| K251726 | Forest Devices, Inc. | SignalNED System (Model RE) | 2025-09-03 | 90 |
| K243185 | Epitel | REMI Remote EEG Monitoring System | 2025-03-21 | 172 |
| K242930 | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Natus BrainWatch System | 2024-11-19 | 56 |
Recalls for OMC devices
openFDA lists no recalls for product code OMC.
Frequently asked questions
What is FDA product code OMC?
OMC is the FDA product code for reduced- montage standard electroencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel.
What device class is OMC?
Class II, regulation 21 CFR 882.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMC?
Across 29 cleared submissions the average was 141 days from receipt to decision (median 90).
Which companies have the most OMC clearances?
Advanced Brain Monitoring, Inc. (3); Cleveland Medical Devices, Inc. (3); Ceribell, Inc. (2); Forest Devices, Inc. (2); Epitel, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code OMC
- Run a recall and safety report across every OMC manufacturer
- Watch product code OMC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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