# PYT: Device, Fertility Diagnostic, Contraceptive, Software Application

- Device class: 2; regulation: 21 CFR 884.5370; FDA's rule: 510(k) required
- FDA decisions: 7
- 510(k) review time 2021–2025: median 114 days (middle half 90–268)
- 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)
- 2018: 1
- 2021: 2
- 2023: 1
- 2024: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K231274: Natural Cycles (2023), cited by 3
- DEN170052: Natural Cycles (2018), cited by 2
- K202897: Natural Cycles (2021), cited by 1

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