Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5450](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5450) → BTT — Humidifier, Respiratory Gas, (Direct Patient Interface) # BTT · Humidifier, Respiratory Gas, (Direct Patient Interface) _Anesthesiology · 21 CFR 868.5450 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT ## Overview - **Product Code:** BTT - **Device Name:** Humidifier, Respiratory Gas, (Direct Patient Interface) - **Regulation:** [21 CFR 868.5450](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5450) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) ## Identification A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 221) Showing 20 most recent of 221 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K254078](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K254078.md) | HVT 2.0 | Vapotherm, Inc. | Apr 13, 2026 | SESE | | [K251448](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K251448.md) | FL-10000U Respiratory Humidifier | Flexicare Medical Limited. | Jan 16, 2026 | SESE | | [K251419](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K251419.md) | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | Jan 14, 2026 | SESE | | [K253479](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K253479.md) | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | Fisher & Paykel Healthcare, Ltd. | Dec 19, 2025 | SESE | | [K250312](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K250312.md) | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small | Medline Industries, LP | Jul 2, 2025 | SESE | | [K251611](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K251611.md) | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) | Fisher & Paykel Healthcare, Ltd. | Jun 25, 2025 | SESE | | [K242717](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K242717.md) | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | Jan 30, 2025 | SESE | | [K241778](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K241778.md) | Hudson RCI Comfort Flo® CubCannula™ | Medline Industries, LP | Dec 19, 2024 | SESE | | [K240163](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K240163.md) | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | Medline Industries, LP | Sep 27, 2024 | SESE | | [K234058](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K234058.md) | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | Fisher & Paykel Healthcare, Ltd. | Aug 8, 2024 | SESE | | [K233707](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K233707.md) | HFT150 | Invent Medical Corporation | Jun 14, 2024 | SESE | | [K233821](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K233821.md) | F&P Optiflow Oxygen Kit (AA451J) | Fisher & Paykel Healthcare, Ltd. | Jun 13, 2024 | SESE | | [K222292](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K222292.md) | F&P myAirvo 3 | Fisher & Paykel Healthcare | May 8, 2024 | SESE | | [K231956](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K231956.md) | F&P Optiflow+ Duet Nasal Cannula | Fisher & Paykel Healthcare, Ltd. | Feb 7, 2024 | SESE | | [K230559](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K230559.md) | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | Medline Industries, Inc. | Oct 26, 2023 | SESE | | [K223863](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K223863.md) | BONHAWA Respiratory Humidifier | Telesair, Inc. | Oct 13, 2023 | SESE | | [K223684](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K223684.md) | F&P 820 Humidification System | Fisher & Paykel Healthcare, Ltd. | Sep 5, 2023 | SESE | | [K231380](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K231380.md) | AirLife DuoTherm™ Humidification System | Vyaire Medical, Inc. | Aug 10, 2023 | SESE | | [K223551](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K223551.md) | Sterile Water for Inhalation in 1L Flexoval ® bottles. | Hometa, Inc. | Aug 3, 2023 | SESE | | [K220703](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT/K220703.md) | F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare | Jun 16, 2023 | SESE | ## Top Applicants - Fisher & Paykel Healthcare, Ltd. — 25 clearances - Fisher & Paykel Allied Products , Ltd. — 11 clearances - Vapotherm, Inc. — 10 clearances - Travenol Laboratories, S.A. — 9 clearances - Respiratory Care, Inc. — 8 clearances --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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