BTT — Humidifier, Respiratory Gas, (Direct Patient Interface) Class II
FDA product code BTT covers "Humidifier, Respiratory Gas, (Direct Patient Interface)", a Class II medical device regulated under 21 CFR 868.5450. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254078 | vapotherm | HVT 2.0 | April 13, 2026 |
| K251448 | flexicare medical limited | FL-10000U Respiratory Humidifier | January 16, 2026 |
| K251419 | laboratorios biogalenic s.a. de c.v | Laboratorios Biogalenic Sterile Water for Inhalation, USP | January 14, 2026 |
| K253479 | fisher and paykel healthcare | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | December 19, 2025 |
| K250312 | medline industries | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo | July 2, 2025 |
| K251611 | fisher and paykel healthcare | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT | June 25, 2025 |
| K242717 | laboratorios biogalenic s.a. de c.v | Laboratorios Biogalenic Sterile Water for Inhalation, USP | January 30, 2025 |
| K241778 | medline industries | Hudson RCI Comfort Flo® CubCannula | December 19, 2024 |
| K240163 | medline industries | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | September 27, 2024 |
| K234058 | fisher and paykel healthcare | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 | August 8, 2024 |
| K233707 | invent medical corporation | HFT150 | June 14, 2024 |
| K233821 | fisher and paykel healthcare | F&P Optiflow Oxygen Kit (AA451J) | June 13, 2024 |
| K222292 | fisher and paykel healthcare | F&P myAirvo 3 | May 8, 2024 |
| K231956 | fisher and paykel healthcare | F&P Optiflow+ Duet Nasal Cannula | February 7, 2024 |
| K230559 | medline industries | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudso | October 26, 2023 |
| K223863 | telesair | BONHAWA Respiratory Humidifier | October 13, 2023 |
| K223684 | fisher and paykel healthcare | F&P 820 Humidification System | September 5, 2023 |
| K231380 | vyaire medical | AirLife DuoTherm Humidification System | August 10, 2023 |
| K223551 | hometa | Sterile Water for Inhalation in 1L Flexoval ® bottles. | August 3, 2023 |
| K220703 | fisher and paykel healthcare | F&P 950 Respiratory Humidifier | June 16, 2023 |