BTT — Humidifier, Respiratory Gas, (Direct Patient Interface) Class II

FDA Device Classification

Classification Details

Product Code
BTT
Device Class
Class II
Regulation Number
868.5450
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251448flexicare medical limitedFL-10000U Respiratory HumidifierJanuary 16, 2026
K251419laboratorios biogalenic s.a. de c.vLaboratorios Biogalenic Sterile Water for Inhalation, USPJanuary 14, 2026
K253479fisher and paykel healthcareOptiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)December 19, 2025
K250312medline industriesHudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort FloJuly 2, 2025
K251611fisher and paykel healthcareOptiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPTJune 25, 2025
K242717laboratorios biogalenic s.a. de c.vLaboratorios Biogalenic Sterile Water for Inhalation, USPJanuary 30, 2025
K241778medline industriesHudson RCI Comfort Flo® CubCannula™December 19, 2024
K240163medline industriesHudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaSeptember 27, 2024
K234058fisher and paykel healthcareF&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041August 8, 2024
K233707invent medical corporationHFT150June 14, 2024
K233821fisher and paykel healthcareF&P Optiflow Oxygen Kit (AA451J)June 13, 2024
K222292fisher and paykel health careF&P myAirvo 3May 8, 2024
K231956fisher and paykel healthcareF&P Optiflow+ Duet Nasal CannulaFebruary 7, 2024
K230559medline industriesHudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), HudsoOctober 26, 2023
K223863telesairBONHAWA Respiratory HumidifierOctober 13, 2023
K223684fisher and paykel healthcareF&P 820 Humidification SystemSeptember 5, 2023
K231380vyaire medicalAirLife DuoTherm™ Humidification SystemAugust 10, 2023
K223551hometaSterile Water for Inhalation in 1L Flexoval ® bottles.August 3, 2023
K220703fisher and paykel health careF&P 950 Respiratory HumidifierJune 16, 2023
K222197fisher and paykel healthcareF&P Optiflow Junior 2/2+ Nasal Cannula Interface RangeApril 6, 2023