FDA product code OMB: Automatic Event Detection Software For Full-Montage Electroencephalograph
OMB is the FDA product code for automatic event detection software for full-montage electroencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel. FDA has cleared 42 510(k) submissions under OMB, 14 in the last five years, from 23 different applicants. The average 510(k) review took 157 days (median 142); 159 days on average over the last three years. FDA has posted 1 recall for OMB devices, 1 initiated in the last five years.
Definition
Automatically mark or identify electroencephalograph waveforms for spikes, electrographic seizures, seizure-like events in order to aid in identification of such events and help review and annotation of prolonged EEG traces; All output subject to verification by qualified user
Classification
| Field | Value |
|---|---|
| Device name | Automatic Event Detection Software For Full-Montage Electroencephalograph |
| Device class | Class II |
| Regulation | 21 CFR 882.1400 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for OMB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 150 |
| 2018 | 3 | 148 |
| 2019 | 1 | 120 |
| 2020 | 1 | 46 |
| 2021 | 1 | 206 |
| 2022 | 1 | 176 |
| 2023 | 2 | 240 |
| 2024 | 5 | 217 |
| 2025 | 5 | 170 |
| 2026 | 1 | 90 |
Compare with all 510(k) review times · Search every OMB clearance
Top OMB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Persyst Development Corporation | 6 | 2025-01-22 |
| Ceribell, Inc. | 5 | 2026-06-24 |
| Excel Tech. , Ltd. | 3 | 2004-09-16 |
| Holberg Eeg AS | 2 | 2025-04-09 |
| LVIS Corporation | 2 | 2024-11-26 |
18 more applicants have OMB clearances. See the full list in Caduvo.
Most recent OMB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260998 | Ceribell, Inc. | Ceribell Neurology Review Software | 2026-06-24 | 90 |
| K252070 | Ceribell, Inc. | Ceribell Infant Seizure Detection Software | 2025-11-21 | 143 |
| K252160 | Persyst Development, LLC | Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) | 2025-10-31 | 113 |
| K241589 | Ceribell, Inc. | Ceribell Seizure Detection Software | 2025-04-09 | 310 |
| K243743 | Holberg Eeg AS | autoSCORE (V 2.0.0) | 2025-04-09 | 126 |
Recalls for OMB devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2021-12-02.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code OMB?
OMB is the FDA product code for automatic event detection software for full-montage electroencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel.
What device class is OMB?
Class II, regulation 21 CFR 882.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMB?
Across 42 cleared submissions the average was 157 days from receipt to decision (median 142).
Which companies have the most OMB clearances?
Persyst Development Corporation (6); Ceribell, Inc. (5); Excel Tech. , Ltd. (3); Holberg Eeg AS (2); LVIS Corporation (2).
Have OMB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-12-02.
Next steps
- Run an FDA pathway report with predicate devices for product code OMB
- Run a recall and safety report across every OMB manufacturer
- Watch product code OMB 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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