BTT · Humidifier, Respiratory Gas, (Direct Patient Interface)
Anesthesiology · 21 CFR 868.5450 · Class 2
Overview
| Product Code | BTT |
|---|---|
| Device Name | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Regulation | 21 CFR 868.5450 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
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 | HVT 2.0 | Vapotherm, Inc. | Apr 13, 2026 | SESE |
| K251448 | FL-10000U Respiratory Humidifier | Flexicare Medical Limited. | Jan 16, 2026 | SESE |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | Jan 14, 2026 | SESE |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | Fisher & Paykel Healthcare, Ltd. | Dec 19, 2025 | SESE |
| K250312 | 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 | 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 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | Jan 30, 2025 | SESE |
| K241778 | Hudson RCI Comfort Flo® CubCannula | Medline Industries, LP | Dec 19, 2024 | SESE |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | Medline Industries, LP | Sep 27, 2024 | SESE |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | Fisher & Paykel Healthcare, Ltd. | Aug 8, 2024 | SESE |
| K233707 | HFT150 | Invent Medical Corporation | Jun 14, 2024 | SESE |
| K233821 | F&P Optiflow Oxygen Kit (AA451J) | Fisher & Paykel Healthcare, Ltd. | Jun 13, 2024 | SESE |
| K222292 | F&P myAirvo 3 | Fisher & Paykel Healthcare | May 8, 2024 | SESE |
| K231956 | F&P Optiflow+ Duet Nasal Cannula | Fisher & Paykel Healthcare, Ltd. | Feb 7, 2024 | SESE |
| K230559 | 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 | BONHAWA Respiratory Humidifier | Telesair, Inc. | Oct 13, 2023 | SESE |
| K223684 | F&P 820 Humidification System | Fisher & Paykel Healthcare, Ltd. | Sep 5, 2023 | SESE |
| K231380 | AirLife DuoTherm Humidification System | Vyaire Medical, Inc. | Aug 10, 2023 | SESE |
| K223551 | Sterile Water for Inhalation in 1L Flexoval ® bottles. | Hometa, Inc. | Aug 3, 2023 | SESE |
| K220703 | 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
