# Laboratorios Biogalenic S.A. DE C.V.

- Location (FDA's records): San Salvador, SV
- FDA decisions: 3 (2025–2026): 3 510(k) clearances
- Product codes: BTT (2), FRO (1)
- 510(k) review time since 2016: median 161 days, against 176 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (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 whose devices it cites most
- Cardinal Health, Inc.: 1 (https://510kreport.com/company/cardinal-health)
- Hometa, Inc.: 1 (https://510kreport.com/company/hometa)
- Medline Industries, Inc.: 1 (https://510kreport.com/company/medline-industries)

## Recent decisions
- K251419: Laboratorios Biogalenic Sterile Water for Inhalation, USP (Jan 14, 2026)
- K243001: Sterile Water USP and Sterile 0.9% Normal Saline USP (Mar 6, 2025)
- K242717: Laboratorios Biogalenic Sterile Water for Inhalation, USP (Jan 30, 2025)

Source page: https://510kreport.com/company/laboratorios-biogalenic