EarliPoint Assessment
FDA 510(k) clearance K253442 · decided 2026-03-05
Clearance details
- K-number
- K253442
- Device name
- EarliPoint Assessment
- Applicant
- Earlitec Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2025-10-01
- Decision date
- 2026-03-05
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- QPF
- Device class
- 2
- Regulation number
- 882.1491
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Earlitec Diagnostics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Canvas Dx (K243558) | Cognoa, Inc. | 2025-04-11 |
| EarliPoint System (K243891) | Earlitec Diagnostics | 2025-03-26 |
| EarliPoint (K230337) | Earlitec Diagnostics, Inc. | 2023-06-29 |
| EarliPoint System (K213882) | Earlitec Diagnostics, Inc. | 2022-06-08 |
| Cognoa ASD Diagnosis Aid (DEN200069) | Cognoa, Inc. | 2021-06-02 |
Recalls involving this device
No recalls on record reference this clearance.