FDA product code OLW: Index-Generating Electroencephalograph Software
OLW is the FDA product code for index-generating electroencephalograph software. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel. FDA has cleared 40 510(k) submissions under OLW, 5 in the last five years, from 19 different applicants. The average 510(k) review took 152 days (median 89); 240 days on average over the last three years. FDA has posted 1 recall for OLW devices.
Definition
Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
Classification
| Field | Value |
|---|---|
| Device name | Index-Generating Electroencephalograph Software |
| 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 OLW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 126 |
| 2021 | 1 | 329 |
| 2022 | 1 | 498 |
| 2023 | 1 | 701 |
| 2024 | 1 | 350 |
| 2026 | 2 | 131 |
Compare with all 510(k) review times · Search every OLW clearance
Top OLW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aspect Medical Systems, Inc. | 12 | 2007-11-20 |
| Physiometrix, Inc. | 4 | 2005-09-02 |
| Masimo Corporation | 3 | 2026-07-10 |
| GE Healthcare | 3 | 2008-03-27 |
| Mennen Medical , Ltd. | 2 | 2008-12-16 |
14 more applicants have OLW clearances. See the full list in Caduvo.
Most recent OLW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260907 | Covidien LP | BIS Advance pEEG Module | 2026-08-13 | 147 |
| K260880 | Masimo Corporation | SedLine Sedation Monitor | 2026-07-10 | 115 |
| K230693 | Covidien, LLC | BIS Advance Monitoring System | 2024-02-26 | 350 |
| K213273 | Cortical Dynamics , Ltd. | Brain Anesthesia Response Monitor (Bar Monitor) | 2023-09-01 | 701 |
| K203113 | Masimo Corporation | Masimo SedLine Sedation Monitor and Accessories | 2022-02-25 | 498 |
Recalls for OLW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2018-07-26.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code OLW?
OLW is the FDA product code for index-generating electroencephalograph software. It is a Class II device, regulated under 21 CFR 882.1400 and reviewed by the Neurology panel.
What device class is OLW?
Class II, regulation 21 CFR 882.1400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLW?
Across 40 cleared submissions the average was 152 days from receipt to decision (median 89).
Which companies have the most OLW clearances?
Aspect Medical Systems, Inc. (12); Physiometrix, Inc. (4); Masimo Corporation (3); GE Healthcare (3); Mennen Medical , Ltd. (2).
Have OLW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-07-26.
Next steps
- Run an FDA pathway report with predicate devices for product code OLW
- Run a recall and safety report across every OLW manufacturer
- Watch product code OLW 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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