BraiN20® (BraiN20)
FDA 510(k) clearance K253301 · decided 2026-06-27
Clearance details
- K-number
- K253301
- Device name
- BraiN20® (BraiN20)
- Applicant
- Time IS Brain, S.L.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-29
- Decision date
- 2026-06-27
- Days to decision
- 271 days
- Clearance type
- Traditional
- Product code
- GWF
- Device class
- 2
- Regulation number
- 882.1870
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Badalona, ES
- Third-party review
- No
- Expedited review
- No
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| MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (K234080) | Soterix Medical, Inc. | 2024-03-25 |
| ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K233292) | Inomed Medizintechnik GmbH | 2023-10-27 |
| Cadwell Guardian (K230415) | Cadwell Industries, Inc. | 2023-08-17 |
| SafeOp 2: Neural Informatix System (K213849) | Alphatec Spine, Inc. | 2022-03-09 |
| ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K212166) | Inomed Medizintechnik GmbH | 2022-01-07 |
| MEGA-TMS (K192823) | Soterix Medical, Inc. | 2021-08-13 |
| Neuro-IOM system with Neuro-IOM.NET software (K190703) | Neurosoft , Ltd. | 2021-05-22 |
Recalls involving this device
No recalls on record reference this clearance.