SedLine Sedation Monitor
FDA 510(k) K172890 · Masimo Corporation
510(k) numberK172890
Submission
- Device name
- SedLine Sedation Monitor
- Applicant
- Masimo Corporation
Irvine, CA, US - Received
- September 22, 2017
- Decision date
- January 26, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLW – Index-Generating Electroencephalograph Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.
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|---|---|---|---|
| K260907 | BIS Advance pEEG ModuleOLW · Traditional | Covidien LP | 08/13/2026SE |
| K260880 | SedLine Sedation MonitorOLW · Traditional | Masimo Corporation | 07/10/2026SE |
| K230693 | BIS Advance Monitoring SystemOLW · Traditional | Covidien, LLC | 02/26/2024SE |
| K213273 | Brain Anesthesia Response Monitor (Bar Monitor)OLW · Traditional | Cortical Dynamics , Ltd. | 09/01/2023SE |
| K203113 | Masimo SedLine Sedation Monitor and AccessoriesOLW · Traditional | Masimo Corporation | 02/25/2022SE |
| K202621 | NeuroSENSE Monitoring System, Model NS-901OLW · Traditional | Neurowave Systems, Inc. | 08/05/2021SE |
| K150298 | Entropy Module, E-ENTROPY-01OLW · Traditional | Ge Healthcare Filand OY | 11/12/2015SE |
| K083063 | Bis Interface for Vitalogik Patient MonitorsOLW · Traditional | Mennen Medical , Ltd. | 12/16/2008SE |
| K061907 | Modification to: Datex-Ohmeda S/5 Entropy Module, E-Entropy and AccessoriesOLW · Traditional | GE Healthcare | 03/27/2008SE |
| K072286 | Bis EEG Vista Monitor System and BisxOLW · Traditional | Aspect Medical Systems, Inc. | 11/20/2007SE |
More from Aspect Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253417 | Masimo Root Monitoring SystemMWI · Traditional | 08/12/2026SE |
| K260880 | SedLine Sedation MonitorOLW · Traditional | 07/10/2026SE |
| K254209 | Radius VSM and AccessoriesMHX · Traditional | 06/04/2026SE |
| K243324 | Masimo O3 Regional OximeterMUD · Traditional | 07/17/2025SE |
| K250757 | Radius VSM and AccessoriesMHX · Traditional | 05/29/2025SE |
| K243305 | Masimo W1DPS · Traditional | 04/03/2025SE |
| K240229 | Masimo W1DPS · Traditional | 08/08/2024SE |
| K234021 | Masimo StorkQYU · Traditional | 05/03/2024SE |
| K214115 | MightySat -OTCOLK · Traditional | 01/31/2024SE |
| K223721 | Masimo StorkDQA · Traditional | 12/15/2023SE |
Questions and answers
When was SedLine Sedation Monitor cleared by the FDA?
SedLine Sedation Monitor (K172890) received a 510(k) decision of Substantially Equivalent on January 26, 2018, 126 days after the submission was received.
What is the product code of K172890?
The FDA product code is OLW – Index-Generating Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.