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FDA 510(k)

FL-10000U Respiratory Humidifier

K-Number: K251448 · 2026-01-16

ApplicantFlexicare Medical Limited.
Decision Date2026-01-16
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FL-10000U Respiratory Humidifier is a medical device manufactured by Flexicare Medical Limited.. It received FDA 510(k) clearance on 2026-01-16 under approval number K251448. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FL-10000U Respiratory Humidifier?

FL-10000U Respiratory Humidifier is a medical device that received FDA 510(k) clearance on 2026-01-16. It is manufactured by Flexicare Medical Limited.. The 510(k) number is K251448.

When was FL-10000U Respiratory Humidifier approved by the FDA?

FL-10000U Respiratory Humidifier received FDA 510(k) clearance on 2026-01-16, under approval number K251448.

What company makes FL-10000U Respiratory Humidifier?

FL-10000U Respiratory Humidifier is manufactured by Flexicare Medical Limited..

What is the FDA product code for FL-10000U Respiratory Humidifier?

The FDA product code for FL-10000U Respiratory Humidifier is BTT.

Related Clinical Trials

NCT02389166 Optiflow in Sequential Non-Invasive Ventilation COMPLETED

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Related Devices (Code: BTT)

K160764AirLife Autofill Humidification ChamberCarefusion 2200, Inc. K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASEFlexicare Medical Limited. K152029HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K161719Salter Labs Bubble HumidifierSalter Labs K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K162242Comfort Flo Humidification SystemTeleflexmedical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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