Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Laboratorios Biogalenic S.A. DE C.V. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | 2026-01-14 | 252 | 0 |
| K243001 | Sterile Water USP and Sterile 0.9% Normal Saline USP | Laboratorios Biogalenic S.A. DE C.V. | 2025-03-06 | 161 | 0 |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | 2025-01-30 | 142 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda