VRNT
FDA 510(k) clearance K254004 · decided 2026-04-10
Clearance details
- K-number
- K254004
- Device name
- VRNT
- Applicant
- Cognifisense, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-15
- Decision date
- 2026-04-10
- Days to decision
- 116 days
- Clearance type
- Special
- Product code
- QRA
- Device class
- 2
- Regulation number
- 890.5800
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RelieVRx (Pico G3) (K251519) | Appliedvr | 2025-08-13 |
| RelieVRx (K243417) | Appliedvr | 2024-12-04 |
| VRNT (K230814) | Cognifisense, Inc. | 2023-10-31 |
| Smileyscope System (Therapy Mode) (K230825) | Smileyscope Holding, Inc. | 2023-09-25 |
| EaseVRx (DEN210014) | Appliedvr, Inc. | 2021-11-16 |
Recalls involving this device
No recalls on record reference this clearance.