# PBH: Embryo Image Assessment System, Assisted Reproduction

- Device class: 2; regulation: 21 CFR 884.6195; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 242 days (middle half 242–242)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 2
- 2019: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K142147: Eeva System (2014), cited by 2
- DEN120015: EEVA 2.0 (2014), cited by 2

Source page: https://510kreport.com/product-code/PBH
Data by year (CSV): https://510kreport.com/product-code/PBH.csv