FDA product code OLU: Normalizing Quantitative Electroencephalograph Software
OLU is the FDA product code for normalizing quantitative electroencephalograph software. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel. FDA has cleared 13 510(k) submissions under OLU, 4 in the last five years, from 13 different applicants. The average 510(k) review took 297 days (median 240); 243 days on average over the last three years.
Definition
Post-hoc statistical analysis of electroencephalograph signals with comparison to a normative database for interpretation by a qualified user.
Classification
| Field | Value |
|---|---|
| Device name | Normalizing Quantitative Electroencephalograph Software |
| Device class | Class II |
| Regulation | 21 CFR 882.1400 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OLU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 412 |
| 2020 | 2 | 165 |
| 2023 | 2 | 350 |
| 2024 | 1 | 220 |
| 2026 | 1 | 266 |
Compare with all 510(k) review times · Search every OLU clearance
Top OLU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| VoxNeuro, Inc. | 1 | 2026-06-12 |
| Neurofield, Inc. | 1 | 2024-09-20 |
| iMediSync, Inc. | 1 | 2023-03-16 |
| Medeia, Inc. | 1 | 2023-01-28 |
| Elminda, Ltd. | 1 | 2020-12-07 |
8 more applicants have OLU clearances. See the full list in Caduvo.
Most recent OLU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253015 | VoxNeuro, Inc. | Cognitive Function Neuroimaging (cfNI) Software (1.0.0) | 2026-06-12 | 266 |
| K240420 | Neurofield, Inc. | NeuroField Analysis Suite | 2024-09-20 | 220 |
| K222838 | iMediSync, Inc. | iSyncBrain©-C | 2023-03-16 | 177 |
| K212684 | Medeia, Inc. | BrainView QEEG Software | 2023-01-28 | 522 |
| K202588 | Elminda, Ltd. | BNA Platform | 2020-12-07 | 90 |
Recalls for OLU devices
openFDA lists no recalls for product code OLU.
Frequently asked questions
What is FDA product code OLU?
OLU is the FDA product code for normalizing quantitative electroencephalograph software. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel.
What device class is OLU?
Class II, regulation 21 CFR 882.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLU?
Across 13 cleared submissions the average was 297 days from receipt to decision (median 240).
Which companies have the most OLU clearances?
VoxNeuro, Inc. (1); Neurofield, Inc. (1); iMediSync, Inc. (1); Medeia, Inc. (1); Elminda, Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OLU
- Run a recall and safety report across every OLU manufacturer
- Watch product code OLU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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