Submission Details
| 510(k) Number | K251419 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 07, 2025 |
| Decision Date | January 14, 2026 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
Laboratorios Biogalenic Sterile Water for Inhalation, USP
Jan 2026
Decision
252d
Days
Class 2
Risk
About This 510(k) Submission
K251419 is an FDA 510(k) clearance for the Laboratorios Biogalenic Sterile Water for Inhalation, USP, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Laboratorios Biogalenic S.A. DE C.V. (San Salvador, SV). The FDA issued a Cleared decision on January 14, 2026, 252 days after receiving the submission on May 7, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.
Device Classification
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5450 |
Manufacturer
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