EarliPoint System
FDA 510(k) clearance K213882 · decided 2022-06-08
Clearance details
- K-number
- K213882
- Device name
- EarliPoint System
- Applicant
- Earlitec Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-13
- Decision date
- 2022-06-08
- Days to decision
- 177 days
- Clearance type
- Traditional
- Product code
- QPF
- Device class
- 2
- Regulation number
- 882.1491
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Atlanta, GA, 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 |
|---|---|---|
| EarliPoint Assessment (K253442) | Earlitec Diagnostics | 2026-03-05 |
| Canvas Dx (K243558) | Cognoa, Inc. | 2025-04-11 |
| EarliPoint System (K243891) | Earlitec Diagnostics | 2025-03-26 |
| EarliPoint (K230337) | Earlitec Diagnostics, Inc. | 2023-06-29 |
| Cognoa ASD Diagnosis Aid (DEN200069) | Cognoa, Inc. | 2021-06-02 |
Recalls involving this device
No recalls on record reference this clearance.