FDA product code OLZ: Automatic Event Detection Software For Polysomnograph With Electroencephalograph
OLZ is the FDA product code for automatic event detection software for polysomnograph with electroencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel. FDA has cleared 37 510(k) submissions under OLZ, 11 in the last five years, from 24 different applicants. The average 510(k) review took 178 days (median 149); 169 days on average over the last three years.
Definition
Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user
Classification
| Field | Value |
|---|---|
| Device name | Automatic Event Detection Software For Polysomnograph With Electroencephalograph |
| Device class | Class II |
| Regulation | 21 CFR 882.1400 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for OLZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 151 |
| 2018 | 1 | 267 |
| 2019 | 2 | 110 |
| 2020 | 1 | 90 |
| 2021 | 1 | 161 |
| 2022 | 1 | 149 |
| 2023 | 2 | 248 |
| 2024 | 2 | 138 |
| 2025 | 4 | 182 |
| 2026 | 2 | 188 |
Compare with all 510(k) review times · Search every OLZ clearance
Top OLZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beacon Biosignals, Inc. | 3 | 2024-11-22 |
| Respironics, Inc. | 3 | 2020-10-29 |
| Embla Systems | 3 | 2017-04-11 |
| Advanced Brain Monitoring, Inc. | 3 | 2016-03-14 |
| Honeynaps Co., Ltd. | 2 | 2026-06-27 |
19 more applicants have OLZ clearances. See the full list in Caduvo.
Most recent OLZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253390 | Honeynaps Co., Ltd. | SOMNUM (SOMNUM) | 2026-06-27 | 270 |
| K253668 | Onera B.V. | Onera SleepMap (SLEEPMAP) | 2026-03-08 | 107 |
| K250851 | Cadwell Industries, Inc. | Hypnos (369054-200) | 2025-12-14 | 268 |
| K252330 | Nox Medical Ehf | DeepRESP | 2025-11-17 | 115 |
| K250058 | Brain Electrophysiology Laboratory Company, LLC | NEAT 001 | 2025-04-10 | 90 |
Recalls for OLZ devices
openFDA lists no recalls for product code OLZ.
Frequently asked questions
What is FDA product code OLZ?
OLZ is the FDA product code for automatic event detection software for polysomnograph with electroencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel.
What device class is OLZ?
Class II, regulation 21 CFR 882.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLZ?
Across 37 cleared submissions the average was 178 days from receipt to decision (median 149).
Which companies have the most OLZ clearances?
Beacon Biosignals, Inc. (3); Respironics, Inc. (3); Embla Systems (3); Advanced Brain Monitoring, Inc. (3); Honeynaps Co., Ltd. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code OLZ
- Run a recall and safety report across every OLZ manufacturer
- Watch product code OLZ 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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