FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
K Number: K251381
·
Decision Oct 31, 2025
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
13
Review Days
182
Basic Information
- Device Name
- Ceribell Instant EEG Headcap (Small: C251, Medium: C252)
- K Number
- K251381
- 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
- May 2, 2025
- Decision Date
- October 31, 2025
- 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 |
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|---|---|---|---|
| K260363 | Ceribell Brain Monitor Headband | Apr 3, 2026 | Substantially Equivalent |
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| 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 |