# Visby Medical, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 6 (2021–2026): 5 510(k) clearances and 1 De Novo grant
- Names in FDA's records: Visby Medical, Inc. (4); Visby Medical (2)
- Product codes: QEP (3), SEA (1), QOF (1), SIA (1)
- 510(k) review time since 2016: median 282 days, against 297 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cepheid: 2 (https://510kreport.com/company/cepheid)
- Diasorin Molecular, LLC: 1 (https://510kreport.com/company/diasorin-molecular)
- Cue Health, Inc.: 1 (https://510kreport.com/company/cue-health)

## Its most-cited devices
- K220407: Visby Medical Sexual Health Test (2023), cited by 1
- K200748: Visby Medical Sexual Health (2021), cited by 1

## Recent decisions
- K253971: Visby Medical Flu and COVID-19 Test (May 27, 2026)
- K251501: Visby Medical Men's Sexual Health Test (Oct 1, 2025)
- DEN240020: Visby Medical Women's Sexual Health Test (Mar 28, 2025)
- K242526: Visby Medical Respiratory Health Test (Feb 19, 2025)
- K220407: Visby Medical Sexual Health Test (Mar 7, 2023)
- K200748: Visby Medical Sexual Health (Aug 26, 2021)

Source page: https://510kreport.com/company/visby-medical