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FDA product code · Neurology · Class 2

OMB: Automatic Event Detection Software For Full-Montage Electroencephalograph

OMB is FDA's product code for "Automatic Event Detection Software For Full-Montage Electroencephalograph": a Class 2 device classified under 21 CFR 882.1400, reviewed by the Neurology panel.

510(k) review time for OMB

Across 20 510(k) clearances under OMB decided from 2018-01-01 to 2026-10-06, the median was 173 days from FDA receipt to decision. Half took between 118 and 217 days, and 80% were decided within 254 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, OMB, decisions 2018-01-01 to 2026-10-06 (n = 20)
Fastest26
25th percentile118
Median173
75th percentile217
80th percentile254
90th percentile299
Slowest311
Median days by decision year, OMB (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20242015
20251435

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.

OMB in the public FDA record

Records naming OMB, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years42

Counts of records, not of devices or events. Adverse event reports for OMB 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 OMB

No FDA recognized consensus standard cites OMB by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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