FDA product code · Neurology · Class 2
OLV: Standard Polysomnograph With Electroencephalograph
OLV is FDA's product code for "Standard Polysomnograph With Electroencephalograph": a Class 2 device classified under 21 CFR 882.1400, reviewed by the Neurology panel.
510(k) review time for OLV
Across 11 510(k) clearances under OLV decided from 2018-01-01 to 2026-10-06, the median was 150 days from FDA receipt to decision. Half took between 106 and 212 days, and 80% were decided within 230 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 106 |
| Median | 150 |
| 75th percentile | 212 |
| 80th percentile | 230 |
| 90th percentile | 269 |
| Slowest | 289 |
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.
OLV in the public FDA record
| 510(k) clearances, all years | 65 |
|---|---|
| Establishment listings | 119 |
| GUDID device identifiers | 492 |
Counts of records, not of devices or events. Adverse event reports for OLV 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 OLV
1 FDA recognized consensus standard cite OLV, 1 of them recognized only in part, among them 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.
- 17-23 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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