Laboratorios Biogalenic Sterile Water for Inhalation, USP— 510(k) K251419

Substantially Equivalent

Laboratorios Biogalenic S.A. DE C.V.

FDA 510(k) clearance K251419 for Laboratorios Biogalenic Sterile Water for Inhalation, USP, Substantially Equivalent on 2026-01-14. Applicant: Laboratorios Biogalenic S.A. DE C.V..

Clearance details

Applicant: Laboratorios Biogalenic S.A. DE C.V.
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2025-05-07
Decision date: 2026-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Salvador, SV

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.