K251419 is an FDA 510(k) clearance for the Laboratorios Biogalenic Sterile Water for Inhalation, USP. This device is classified as 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 FDA review panel. Regulated under 21 CFR 868.5450.
| 510(k) Number | K251419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | BTT - Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5450 |