Home / 510(k) Clearances / K251448

510(k) K251448

FL-10000U Respiratory Humidifier by Flexicare Medical Limited. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2026
Date Received
May 9, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Flexicare Medical Limited.

  • K250243 — ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); (May 20, 2025)
  • K201666 — SINGLE USE MANOMETER (November 13, 2020)
  • K191909 — HepaShield Bacterial Viral Breathing System Filter (March 23, 2020)
  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K163300 — ThermoShield HME Filter (March 22, 2017)
  • K161314 — FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE (July 6, 2016)
  • K160540 — FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM (June 23, 2016)

Other clearances for product code BTT

  • K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 14, 2026)
  • K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (December 19, 2025)
  • K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo (July 2, 2025)
  • K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT (June 25, 2025)
  • K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 30, 2025)
  • K241778 — Hudson RCI Comfort Flo® CubCannula™ (December 19, 2024)
  • K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (September 27, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233707 — HFT150 (June 14, 2024)
  • K233821 — F&P Optiflow Oxygen Kit (AA451J) (June 13, 2024)