BTT
- Product code
- BTT
- Device name
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5450
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 17
- Summaries archived here
- 16 (direct download)
- 510(k) clearances (all years, FDA)
- 222 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (17)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K262268 | 2026-08-27 | Fisher and Paykel Healthcare Limited | Optiflow Oxygen Kit (AA484J) | |
| K254078 | 2026-04-13 | Vapotherm, Inc. | HVT 2.0 | |
| K251448 | 2026-01-16 | Flexicare Medical Limited. | FL-10000U Respiratory Humidifier | |
| K251419 | 2026-01-14 | Laboratorios Biogalenic S.A. DE C.V. | Laboratorios Biogalenic Sterile Water for Inhalation… | FDA |
| K253479 | 2025-12-19 | Fisher & Paykel Healthcare, Ltd. | Optiflow Switch+ Filtered Nasal Interface with CO2 S… | |
| K250312 | 2025-07-02 | Medline Industries, LP | Hudson RCI® Comfort Flo Nasal Cannula Premature, Inf… | |
| K251611 | 2025-06-25 | Fisher & Paykel Healthcare, Ltd. | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ … | |
| K242717 | 2025-01-30 | Laboratorios Biogalenic S.A. DE C.V. | Laboratorios Biogalenic Sterile Water for Inhalation… | |
| K241778 | 2024-12-19 | Medline Industries, LP | Hudson RCI Comfort Flo® CubCannula | |
| K240163 | 2024-09-27 | Medline Industries, LP | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® C… | |
| K234058 | 2024-08-08 | Fisher & Paykel Healthcare, Ltd. | F&P Optiflow Filtered Nasal Interface with Anesthesi… | |
| K233707 | 2024-06-14 | Invent Medical Corporation | HFT150 | |
| K233821 | 2024-06-13 | Fisher & Paykel Healthcare, Ltd. | F&P Optiflow Oxygen Kit (AA451J) | |
| K222292 | 2024-05-08 | Fisher & Paykel Healthcare | F&P myAirvo 3 | |
| K231956 | 2024-02-07 | Fisher & Paykel Healthcare, Ltd. | F&P Optiflow+ Duet Nasal Cannula | |
| K230559 | 2023-10-26 | Medline Industries, Inc. | Hudson RCI® Disposable Humidifier with 4 PSI Pressur… | |
| K223863 | 2023-10-13 | Telesair, Inc. | BONHAWA Respiratory Humidifier |
Official FDA classification page: BTT
Classification and pathway per current FDA publications. Data from openFDA (CC0).