BIS Pediatric Sensor
by Aspect Medical Systems, Inc. 510(k)
Active
510(k) K041670
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041670 | Date6 Jul 2004 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GXY
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.1320
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The BIS Pediatric Sensor is a cutaneous electrode designed to capture EEG signals from the frontal brain cortex for display on the BIS monitor. It is intended for use in children aged 4 and above. The device is classified under product code GXY and regulatory class II.
The BIS Pediatric Sensor is supplied as a single-use device and requires proper storage conditions. It received FDA 510(k) clearance on July 6, 2004, with K number K041670, under the regulation 21 CFR 882.1320 for cutaneous electrodes. The device is not indicated for MRI use.
Other devices from Aspect Medical Systems, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the BIS Pediatric Sensor used for?
The BIS Pediatric Sensor is designed to capture EEG signals from the frontal brain cortex for display on the BIS monitor, specifically intended for use in children aged 4 and above to monitor brain activity during medical procedures.
Is the BIS Pediatric Sensor reusable or single-use?
The BIS Pediatric Sensor is supplied as a single-use device, meaning it is intended for one patient and one procedure only, and should be discarded after use to prevent cross-contamination and ensure signal integrity.
How should the BIS Pediatric Sensor be stored?
The BIS Pediatric Sensor requires proper storage conditions as specified by the manufacturer to maintain its functionality and sterility until use, though specific temperature or humidity details are not provided in the device data.
What regulatory pathway was used for the BIS Pediatric Sensor?
The BIS Pediatric Sensor received FDA 510(k) clearance on July 6, 2004, under K number K041670, demonstrating substantial equivalence to a legally marketed predicate device under regulation 21 CFR 882.1320 for cutaneous electrodes.
Can the BIS Pediatric Sensor be used during MRI procedures?
The BIS Pediatric Sensor is not indicated for MRI use, meaning it should not be used in magnetic resonance imaging environments due to potential safety risks or interference with imaging quality.