# LHD: Device, Fertility Diagnostic, Proceptive

- Device class: U; regulation: 21 CFR —
- FDA decisions: 24
- 510(k) review time 2021–2025: median 363 days (middle half 363–363)
- 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)
- 1988: 1
- 1990: 1
- 1992: 1
- 1995: 2
- 2001: 1
- 2003: 2
- 2006: 1
- 2011: 1
- 2013: 1
- 2021: 1

## Most-cited predicates
- K050094: Lady Comp Usa (2006), cited by 2
- K901512: L Sophia (1990), cited by 1
- K904211: Bioself 2000 Fertility Indicator (1992), cited by 1
- K102499: Duofertility (2011), cited by 1
- K021978: Petit Sophia (2003), cited by 1
- K945427: B-D Digital Thermometer (1995), cited by 1
- K002726: Tcoyf Fertility Software Version 1.0 (2001), cited by 1

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