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FDA product code · Neurology · Class 2

OLZ: Automatic Event Detection Software For Polysomnograph With Electroencephalograph

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

510(k) review time for OLZ

Across 16 510(k) clearances under OLZ decided from 2018-01-01 to 2026-10-06, the median was 152 days from FDA receipt to decision. Half took between 113 and 257 days, and 80% were decided within 267 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, OLZ, decisions 2018-01-01 to 2026-10-06 (n = 16)
Fastest65
25th percentile113
Median152
75th percentile257
80th percentile267
90th percentile268
Slowest270

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.

OLZ in the public FDA record

Records naming OLZ, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years37

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

No FDA recognized consensus standard cites OLZ 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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