FDA product code OMA: Amplitude-Integrated Electroencephalograph
OMA is the FDA product code for amplitude-integrated electroencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel. FDA has cleared 16 510(k) submissions under OMA, from 14 different applicants. The average 510(k) review took 206 days (median 190). FDA has posted 3 recalls for OMA devices, 2 initiated in the last five years.
Definition
Measure and record electrical activity of the brain by acquisition of amplitude-integrated electroencephalograph (electroencephalograph signals that have been filtered and displayed in a specific manner).
Classification
| Field | Value |
|---|---|
| Device name | Amplitude-Integrated 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 OMA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 147 |
| 2020 | 1 | 112 |
Compare with all 510(k) review times · Search every OMA clearance
Top OMA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nihon Kohden America, Inc. | 2 | 2012-03-16 |
| Olympic Medical Corp. | 2 | 2003-05-14 |
| Eemagine Medical Imaging Solutions GmbH | 1 | 2020-01-30 |
| Nihon Kohden Corporation | 1 | 2017-05-19 |
| Cadwell Industries, Inc. | 1 | 2016-11-08 |
9 more applicants have OMA clearances. See the full list in Caduvo.
Most recent OMA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192889 | Eemagine Medical Imaging Solutions GmbH | Neo | 2020-01-30 | 112 |
| K163644 | Nihon Kohden Corporation | Nihon Kohden QP-160AK EEG Trend Program | 2017-05-19 | 147 |
| K161027 | Cadwell Industries, Inc. | Cadwell AmpliScan | 2016-11-08 | 210 |
| K152301 | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Background Pattern Classification [BPc(TM)] | 2016-06-03 | 294 |
| K130238 | Nihon Kohden Corp. | NIHON KOHDEN AE-918P NEURO UNIT | 2015-03-04 | 762 |
Recalls for OMA devices
3 product recalls in 3 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-05-07.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2023 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code OMA?
OMA is the FDA product code for amplitude-integrated electroencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel.
What device class is OMA?
Class II, regulation 21 CFR 882.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMA?
Across 16 cleared submissions the average was 206 days from receipt to decision (median 190).
Which companies have the most OMA clearances?
Nihon Kohden America, Inc. (2); Olympic Medical Corp. (2); Eemagine Medical Imaging Solutions GmbH (1); Nihon Kohden Corporation (1); Cadwell Industries, Inc. (1).
Have OMA devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2025-05-07.
Next steps
- Run an FDA pathway report with predicate devices for product code OMA
- Run a recall and safety report across every OMA manufacturer
- Watch product code OMA 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.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times