Embryo Predict
FDA 510(k) clearance K250781 · decided 2026-05-15
Clearance details
- K-number
- K250781
- Device name
- Embryo Predict
- Applicant
- Alife Health
- Decision
- Substantially Equivalent
- Date received
- 2025-03-14
- Decision date
- 2026-05-15
- Days to decision
- 427 days
- Clearance type
- Traditional
- Product code
- PBH
- Device class
- 2
- Regulation number
- 884.6195
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Alife Health
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 |
|---|---|---|
| CHLOE BLAST (K243851) | Fairtility , Ltd. | 2025-08-15 |
| KIDScore D3 (K182798) | Vitrolife A/S | 2019-07-19 |
| EEVA SYSTEM (K142147) | Auxogyn, Inc. | 2014-11-24 |
| EEVA 2.0 (DEN120015) | Auxogyn, Inc. | 2014-06-06 |
Recalls involving this device
No recalls on record reference this clearance.