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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 / K251448

510(k) cleared

FL-10000U Respiratory Humidifier

Flexicare Medical Limited. · Jan 16, 2026 · K251448

FDA cleared the FL-10000U Respiratory Humidifier from Flexicare Medical Limited. on Jan 16, 2026 under K251448, 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 9, 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 Flexicare Medical Limited. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251448?

K251448 is the FDA 510(k) for FL-10000U Respiratory Humidifier, submitted by Flexicare Medical Limited.. FDA's decision date was Jan 16, 2026, under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)).

Who makes the FL-10000U Respiratory Humidifier?

Flexicare Medical Limited., based in Rhondda Cynon Taf, is the applicant of record for K251448.

How long did the K251448 review take?

FDA received the submission on May 9, 2025 and issued its decision on Jan 16, 2026, 252 days later.

← All decisions in January 2026