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FDA product code · Neurology · Class 2

OLT: Non-Normalizing Quantitative Electroencephalograph Software

OLT is FDA's product code for "Non-Normalizing Quantitative Electroencephalograph Software": a Class 2 device classified under 21 CFR 882.1400, reviewed by the Neurology panel.

510(k) review time for OLT

Across 11 510(k) clearances under OLT decided from 2018-01-01 to 2026-10-06, the median was 217 days from FDA receipt to decision. Half took between 165 and 238 days, and 80% were decided within 243 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, OLT, decisions 2018-01-01 to 2026-10-06 (n = 11)
Fastest90
25th percentile165
Median217
75th percentile238
80th percentile243
90th percentile252
Slowest303

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.

OLT in the public FDA record

Records naming OLT, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years56
Establishment listings176

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

No FDA recognized consensus standard cites OLT 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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