FDA product code OLT: Non-Normalizing Quantitative Electroencephalograph Software
OLT is the FDA product code for non-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 57 510(k) submissions under OLT, 8 in the last five years, from 47 different applicants. The average 510(k) review took 174 days (median 160); 176 days on average over the last three years.
Definition
Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user.
Classification
| Field | Value |
|---|---|
| Device name | Non-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 OLT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 166 |
| 2020 | 1 | 252 |
| 2022 | 2 | 262 |
| 2024 | 1 | 175 |
| 2025 | 2 | 164 |
| 2026 | 3 | 189 |
Compare with all 510(k) review times · Search every OLT clearance
Top OLT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pascall Systems, Inc. | 2 | 2026-08-19 |
| Neurosoft , Ltd. | 2 | 2022-11-30 |
| Kvikna Ehf | 2 | 2015-08-21 |
| Brainz Instruments , Ltd. | 2 | 2003-10-10 |
| Neuro Scan Labs | 2 | 2000-11-24 |
42 more applicants have OLT clearances. See the full list in Caduvo.
Most recent OLT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261712 | Ceribell, Inc. | Ceribell EEG Analysis Software | 2026-09-16 | 117 |
| K254213 | Pascall Systems, Inc. | Pascall Sensor Unit (PSU1) | 2026-08-19 | 233 |
| K253767 | Universal Brain | UB ERP System | 2026-06-30 | 217 |
| K251881 | Hippoclinic | HippoMind (v1.0) | 2025-12-03 | 168 |
| K251366 | Nihon Kohden Corporation | EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A) | 2025-10-09 | 161 |
Recalls for OLT devices
openFDA lists no recalls for product code OLT.
Frequently asked questions
What is FDA product code OLT?
OLT is the FDA product code for non-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 OLT?
Class II, regulation 21 CFR 882.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLT?
Across 57 cleared submissions the average was 174 days from receipt to decision (median 160).
Which companies have the most OLT clearances?
Pascall Systems, Inc. (2); Neurosoft , Ltd. (2); Kvikna Ehf (2); Brainz Instruments , Ltd. (2); Neuro Scan Labs (2).
Next steps
- Run an FDA pathway report with predicate devices for product code OLT
- Run a recall and safety report across every OLT manufacturer
- Watch product code OLT 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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