Laboratorios Biogalenic Sterile Water for Inhalation, USP

FDA 510(k) K251419 · Laboratorios Biogalenic S.A. DE C.V.

Substantially Equivalent

510(k) numberK251419

Submission

Device name
Laboratorios Biogalenic Sterile Water for Inhalation, USP
Applicant
Laboratorios Biogalenic S.A. DE C.V.
San Salvador, SV
Received
May 7, 2025
Decision date
January 14, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5450
Specialty
Anesthesiology

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K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special Fisher & Paykel Healthcare, Ltd.06/25/2025SE
K242717Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional Laboratorios Biogalenic S.A. DE C.V.01/30/2025SE
K241778Hudson RCI Comfort Flo® CubCannula™BTT · Traditional Medline Industries, LP12/19/2024SE
K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional Medline Industries, LP09/27/2024SE
K234058F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)BTT · Traditional Fisher & Paykel Healthcare, Ltd.08/08/2024SE

More from Fisher & Paykel Healthcare, Ltd.

510(k)DeviceDecision
K243001Sterile Water USP and Sterile 0.9% Normal Saline USPFRO · Traditional 03/06/2025SE
K242717Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional 01/30/2025SE

Questions and answers

When was Laboratorios Biogalenic Sterile Water for Inhalation, USP cleared by the FDA?

Laboratorios Biogalenic Sterile Water for Inhalation, USP (K251419) received a 510(k) decision of Substantially Equivalent on January 14, 2026, 252 days after the submission was received.

What is the product code of K251419?

The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.