FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ceribell Brain Monitor Headband
K Number: K260363
·
Decision Apr 3, 2026
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
13
Review Days
58
Basic Information
- Device Name
- Ceribell Brain Monitor Headband
- K Number
- K260363
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ceribell, Inc.
- Date Received
- February 4, 2026
- Decision Date
- April 3, 2026
- Product Code
- GXY
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXY), ordered by most recent decision date.
BioWave BioWraps
FDA 510(k)
FDA Class 2
·Neurology
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
FDA 510(k)
FDA Class 2
·Neurology
MR Conditional Cup Electrodes
FDA 510(k)
FDA Class 2
·Neurology
Tutamen Self Adhesive Electrodes
FDA 510(k)
FDA Class 2
·Neurology
myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
FDA 510(k)
FDA Class 2
·Neurology
Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Ceribell, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254033 | Ceribell Instant EEG Headset | Feb 9, 2026 | Substantially Equivalent |
| K251936 | Ceribell Delirium Monitor System | Dec 8, 2025 | Substantially Equivalent |
| K252070 | Ceribell Infant Seizure Detection Software | Nov 21, 2025 | Substantially Equivalent |
| K251381 | Ceribell Instant EEG Headcap (Small: C251, Medium: C252) | Oct 31, 2025 | Substantially Equivalent |
| K241589 | Ceribell Seizure Detection Software | Apr 9, 2025 | Substantially Equivalent |
| K232052 | Ceribell Instant EEG Headband | Aug 8, 2023 | Substantially Equivalent |
| K223504 | Ceribell Status Epilepticus Monitor | May 23, 2023 | Substantially Equivalent |
| K223086 | Ceribell Instant EEG Headcap | Mar 22, 2023 | Substantially Equivalent |
| K210805 | Ceribell Instant EEG Headband | Aug 30, 2021 | Substantially Equivalent |
| K191301 | Ceribell Pocket EEG Device | Sep 11, 2019 | Substantially Equivalent |