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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K251419

510(k) cleared

Laboratorios Biogalenic Sterile Water for Inhalation, USP

Laboratorios Biogalenic S.A. DE C.V. · Jan 14, 2026 · K251419

FDA cleared the Laboratorios Biogalenic Sterile Water for Inhalation, USP from Laboratorios Biogalenic S.A. DE C.V. on Jan 14, 2026 under K251419, a traditional 510(k). The device falls under product code BTT, Humidifier, Respiratory Gas, (Direct Patient Interface), regulated at 21 CFR 868.5450 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on May 7, 2025. The decision came 252 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Laboratorios Biogalenic S.A. DE C.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251419?

K251419 is the FDA 510(k) for Laboratorios Biogalenic Sterile Water for Inhalation, USP, submitted by Laboratorios Biogalenic S.A. DE C.V.. FDA's decision date was Jan 14, 2026, under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)).

Who makes the Laboratorios Biogalenic Sterile Water for Inhalation, USP?

Laboratorios Biogalenic S.A. DE C.V., based in San Salvador, is the applicant of record for K251419.

How long did the K251419 review take?

FDA received the submission on May 7, 2025 and issued its decision on Jan 14, 2026, 252 days later.

← All decisions in January 2026