Cleared Traditional

K251448 - FL-10000U Respiratory Humidifier

K251448 is an FDA 510(k) clearance for FL-10000U Respiratory Humidifier, manufactured by Flexicare Medical Limited.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K251448 · Flexicare Medical Limited. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jan 2026
Decision
252d
Days
Class 2
Risk

K251448 is an FDA 510(k) clearance for the FL-10000U Respiratory Humidifier. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Flexicare Medical Limited. (Rhondda Cynon Taf, GB). The FDA issued a Cleared decision on January 16, 2026 after a review of 252 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Flexicare Medical Limited. devices

FDA 510(k) Submission Details - K251448

510(k) Number K251448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 140d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 109
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