# Bioself, Inc.

- Location (FDA's records): Thonex-Geneve-Suisse, CH
- FDA decisions: 3 (1983–1992): 3 510(k) clearances
- Product codes: LHD (3)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Fertility Focus, Ltd.: 1 (https://510kreport.com/company/fertility-focus)

## Its most-cited devices
- K904211: Bioself 2000 Fertility Indicator (1992), cited by 1

## Recent decisions
- K904211: Bioself 2000 Fertility Indicator (Oct 14, 1992)
- K843699: Bioself TM 110 (Dec 4, 1984)
- K823209: Bioself 101 (Feb 15, 1983)

Source page: https://510kreport.com/company/bioself