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Panels › Anesthesiology › Product code BTT · Class 2

Humidifier, Respiratory Gas, (Direct Patient Interface)

Regulation 868.5450

5510(k)s in 12 months (222 all time)
1recalls in 12 months (70 all time)
66recalls that name a 510(k)
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Top companies in BTT

Company510(k)sRecalls
Teleflex Medical241
Fisher & Paykel Healthcare288
Vapotherm, Inc.1010
Fisher & Paykel Allied Products , Ltd.110
Travenol Laboratories, S.A.90
Respiratory Care, Inc.80
Automatic Liquid Packaging, Inc.60
Fisher & Paykel Electronics , Ltd.60
Hudson Respiratory Care, Inc.51
Respironics, Inc.42
Decided510(k)Device and applicantCode
Aug 27, 2026K262268Optiflow Oxygen Kit (AA484J)
Fisher and Paykel Healthcare Limited, NZ
BTT
Apr 13, 2026K254078HVT 2.0
Vapotherm, Inc.
BTT
Jan 16, 2026K251448FL-10000U Respiratory Humidifier
Flexicare Medical Limited., GB
BTT
Jan 14, 2026K251419Laboratorios Biogalenic Sterile Water for Inhalation, USP
Laboratorios Biogalenic S.A. DE C.V., SV
BTT
Dec 19, 2025K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Jul 2, 2025K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
Medline Industries, LP
BTT
Jun 25, 2025K251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (O
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Jan 30, 2025K242717Laboratorios Biogalenic Sterile Water for Inhalation, USP
Laboratorios Biogalenic S.A. DE C.V., SV
BTT
Dec 19, 2024K241778Hudson RCI Comfort Flo® CubCannula™
Medline Industries, LP
BTT
Sep 27, 2024K240163Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula
Medline Industries, LP
BTT
Aug 8, 2024K234058F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Jun 14, 2024K233707HFT150
Invent Medical Corporation
BTT
Jun 13, 2024K233821F&P Optiflow Oxygen Kit (AA451J)
Fisher & Paykel Healthcare, Ltd., NZ
BTT
May 8, 2024K222292F&P myAirvo 3
Fisher & Paykel Healthcare, NZ
BTT
Feb 7, 2024K231956F&P Optiflow+ Duet Nasal Cannula
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Oct 26, 2023K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI
Medline Industries, Inc.
BTT
Oct 13, 2023K223863BONHAWA Respiratory Humidifier
Telesair, Inc.
BTT
Sep 5, 2023K223684F&P 820 Humidification System
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Aug 10, 2023K231380AirLife DuoTherm™ Humidification System
Vyaire Medical, Inc.
BTT
Aug 3, 2023K223551Sterile Water for Inhalation in 1L Flexoval ® bottles.
Hometa, Inc.
BTT
Jun 16, 2023K220703F&P 950 Respiratory Humidifier
Fisher & Paykel Healthcare, NZ
BTT
Apr 6, 2023K222197F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Dec 21, 2022K222351inspired™ VHB20 Heated Humidifier
Vincent Healthcare Products Limited, HK
BTT
Apr 22, 2022K212031F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Jan 28, 2022K211096Optiflow Oxygen Kit
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Aug 25, 2021K203357HVT 2.0
Vapotherm, Inc.
BTT
Mar 16, 2021K201723F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Nov 12, 2020K193411O2asis Personal Oxygen Humidifier
Perma Pure, LLC
BTT
Mar 19, 2020K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Oct 10, 2019K191010Palladium High Flow Therapy System
Vapotherm, Inc.
BTT
Dec 20, 2018K162553AirSpiral Heated Breathing Tube
Fisher & Paykel Healthcare, NZ
BTT
Oct 18, 2018K180474TNI softFlow 50
Tni Medical AG, DE
BTT
Sep 21, 2017K161719Salter Labs Bubble Humidifier
Salter Labs
BTT
Sep 20, 2017K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
Hamilton Medical AG, CH
BTT
Jan 19, 2017K162242Comfort Flo Humidification System
Teleflexmedical, Inc.
BTT
Aug 25, 2016K160764AirLife Autofill Humidification Chamber
Carefusion 2200, Inc.
BTT
Jul 6, 2016K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
Flexicare Medical Limited., GB
BTT
May 3, 2016K152029HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
Hamilton Medical AG, CH
BTT
Mar 5, 2015K143646MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Nov 24, 2014K141940CONCHASMART COLUMN
Teleflex, Inc.
BTT
Nov 24, 2014K133766HUMICARE D900
Gruendler GmbH
BTT
Sep 24, 2014K140556CONCHASMART BREATHING CIRCUIT
Teleflex, Inc.
BTT
Aug 1, 2014K141353HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR
Teleflexmedical, Inc.
BTT
May 1, 2014K132857RESPIRATORY GAS HUMIDIFIER
Pacific Medico Co., Ltd., JP
BTT
Mar 25, 2014K132017HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Mar 6, 2014K131912CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
Teleflex, Inc.
BTT
Dec 4, 2013K131957MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Oct 24, 2013K131895AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
Fisher & Paykel Healthcare, Ltd., NZ
BTT
Sep 26, 2013K131388TRANSCEND HEATED HUMIDIFIER
Somnetics International, Inc.
BTT
Aug 29, 2013K122885MEDISIZE GOLD HEATER AND BOOSTER T-PIECE
Medisize BV, NL
BTT

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