Prismira
FDA 510(k) clearance K243729 · decided 2025-06-13
Clearance details
- K-number
- K243729
- Device name
- Prismira
- Applicant
- Lumos Labs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-12-03
- Decision date
- 2025-06-13
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- QFT
- Device class
- 2
- Regulation number
- 882.5803
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- San Francisco, 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 |
|---|---|---|
| EndeavorOTC (K233496) | Akili Interactive Labs, Inc. | 2024-06-14 |
| EndeavorRx (K231337) | Akili Interactive Labs, Inc. | 2023-12-13 |
| EndeavorRx (DEN200026) | Akili Interactive Labs, Inc. | 2020-06-15 |
Recalls involving this device
No recalls on record reference this clearance.