FDA product code · Neurology · Class 2
OMC: Reduced- Montage Standard Electroencephalograph
OMC is FDA's product code for "Reduced- Montage Standard Electroencephalograph": a Class 2 device classified under 21 CFR 882.1400, reviewed by the Neurology panel.
510(k) review time for OMC
Across 13 510(k) clearances under OMC decided from 2018-01-01 to 2026-10-06, the median was 90 days from FDA receipt to decision. Half took between 88 and 172 days, and 80% were decided within 182 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 88 |
| Median | 90 |
| 75th percentile | 172 |
| 80th percentile | 182 |
| 90th percentile | 261 |
| Slowest | 396 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
OMC in the public FDA record
| Establishment listings | 141 |
|---|
Counts of records, not of devices or events. Adverse event reports for OMC are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite OMC
2 FDA recognized consensus standards cite OMC, 1 of them recognized only in part, among them IEEE Std 2010-2023; IEC 80601-2-26 First Edition 2024-03 CONSOLIDATED VERSION. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 17-18 IEEE Std 2010-2023 — Recommended Practice for Electroencephalography (EEG) Neurofeedback Systems
- 17-23 IEC 80601-2-26 First Edition 2024-03 CONSOLIDATED VERSION (partial recognition) — Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.
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