PBH
5 FDA 510(k) clearances · Product code
290 daysmedian time to decision
651 days90th percentile
5clearances measured
FDA profile
- Official device name
- Embryo Image Assessment System, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6195
- Medical specialty
- Obstetrics/Gynecology
- FDA definition
- The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Embryo Predict (K250781) | Alife Health | 2026-05-15 |
| 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 |
Track PBH automatically
Every clearance here is in the API, with alerts when new ones post.