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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.

Flexicare Medical Limited. has one other decision in the tracker over the last 12 months: K254026 (3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)).

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

Sources