Cleared Traditional

FL-10000U Respiratory Humidifier

K251448 · Flexicare Medical Limited. · Anesthesiology
Jan 2026
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K251448 is an FDA 510(k) clearance for the FL-10000U Respiratory Humidifier, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Flexicare Medical Limited. (Rhondda Cynon Taf, GB). The FDA issued a Cleared decision on January 16, 2026, 252 days after receiving the submission on May 9, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.

Submission Details

510(k) Number K251448 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2025
Decision Date January 16, 2026
Days to Decision 252 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTT — Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5450

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