Laboratorios Biogalenic Sterile Water for Inhalation, USP

FDA 510(k) K242717 · Laboratorios Biogalenic S.A. DE C.V.

Substantially Equivalent

510(k) numberK242717

Submission

Device name
Laboratorios Biogalenic Sterile Water for Inhalation, USP
Applicant
Laboratorios Biogalenic S.A. DE C.V.
San Salvador, SV
Received
September 10, 2024
Decision date
January 30, 2025
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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K251448FL-10000U Respiratory HumidifierBTT · Traditional Flexicare Medical Limited.01/16/2026SE
K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional Laboratorios Biogalenic S.A. DE C.V.01/14/2026SE
K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special Fisher & Paykel Healthcare, Ltd.12/19/2025SE
K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional Medline Industries, LP07/02/2025SE
K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special Fisher & Paykel Healthcare, Ltd.06/25/2025SE
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
K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional 01/14/2026SE
K243001Sterile Water USP and Sterile 0.9% Normal Saline USPFRO · Traditional 03/06/2025SE

Questions and answers

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

Laboratorios Biogalenic Sterile Water for Inhalation, USP (K242717) received a 510(k) decision of Substantially Equivalent on January 30, 2025, 142 days after the submission was received.

What is the product code of K242717?

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