RD Sedline
The RD SedLine Pediatric EEG Sensor records electrical signals from the forehead in patients aged 1 to 17 years. It is used with the SedLine system to monitor brain activity in operating…
The RD SedLine Pediatric EEG Sensor records electrical signals from the forehead in patients aged 1 to 17 years. It is used with the SedLine system to monitor brain activity in operating rooms, intensive care units and clinical research laboratories.
Electrodes applied directly to the skin detect small voltage differences associated with brain activity. A SedLine patient cable carries these signals to the separate SedLine module, which processes the EEG for display on a compatible host monitor such as Masimo Root.
Listed Item
RD Sedline EEG Sensor Pediatric
Pediatric Monitoring
Pediatric sensor configurations accommodate different forehead sizes. The system does not display the Patient State Index when pediatric sensors are used, because that computed index is not indicated for pediatric patients. SedLine requires its specified Masimo sensors and cables.
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Record
| Listed by | Masimo Corporation, United States |
|---|---|
| FDA product code | OLW |
| Device type | Index-Generating Electroencephalograph Software |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K203113 |
| Record published | 2021-05-13 |
| Record revised | 2025-12-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment humidity 10 to 95 % RH; Storage environment humidity 10 to 95 % RH; Handling environment temperature -40 to 70 °C; Storage environment temperature -40 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4298 | In distribution | ||
| 4329 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BIS | Covidien LP | 57 |
| SedLine | Masimo Corporation | 2 |
| EEG Module w/ Cable | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| B1X5 Software Upgrade | GE Medical Systems Information Technologies, Inc. | 1 |
| BIS Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| BIS module (w accessory kit) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| NeuroSENSE | Neurowave Systems Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260880 | 2026-07-10 |
| K203113 | 2022-02-25 |
| K172890 | 2018-01-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.