FDA product code OLV: Standard Polysomnograph With Electroencephalograph
OLV is the FDA product code for standard polysomnograph with electroencephalograph. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel. FDA has cleared 65 510(k) submissions under OLV, 6 in the last five years, from 37 different applicants. The average 510(k) review took 122 days (median 88); 166 days on average over the last three years. FDA has posted 1 recall for OLV devices.
Definition
Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
Classification
| Field | Value |
|---|---|
| Device name | Standard Polysomnograph With Electroencephalograph |
| 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 OLV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 119 |
| 2018 | 3 | 144 |
| 2020 | 2 | 132 |
| 2022 | 1 | 289 |
| 2024 | 2 | 250 |
| 2025 | 1 | 188 |
| 2026 | 2 | 59 |
Compare with all 510(k) review times · Search every OLV clearance
Top OLV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nihon Kohden America, Inc. | 9 | 2008-01-11 |
| Neurotronics, Inc. | 5 | 2018-11-16 |
| Grass-Telefactor Product Group | 4 | 1999-08-06 |
| Bio-Logic Systems Corp. | 3 | 2005-08-26 |
| Nox Medical Ehf | 2 | 2026-03-20 |
32 more applicants have OLV clearances. See the full list in Caduvo.
Most recent OLV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261747 | Beacon Biosignals, Inc. | Report Studio | 2026-08-25 | 90 |
| K260585 | Nox Medical Ehf | Noxturnal Web | 2026-03-20 | 28 |
| K242447 | Compumedics Limited | Falcon HST | 2025-02-20 | 188 |
| K241288 | Nox Medical Ehf | Noxturnal Web | 2024-12-23 | 230 |
| K240700 | Somnomedics GmbH | HomeSleepTest (HST, HST REM+) | 2024-12-08 | 269 |
Recalls for OLV devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-02-01.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code OLV?
OLV is the FDA product code for standard 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 OLV?
Class II, regulation 21 CFR 882.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLV?
Across 65 cleared submissions the average was 122 days from receipt to decision (median 88).
Which companies have the most OLV clearances?
Nihon Kohden America, Inc. (9); Neurotronics, Inc. (5); Grass-Telefactor Product Group (4); Bio-Logic Systems Corp. (3); Nox Medical Ehf (2).
Have OLV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-02-01.
Next steps
- Run an FDA pathway report with predicate devices for product code OLV
- Run a recall and safety report across every OLV manufacturer
- Watch product code OLV 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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