Product code BTT
- Device name
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5450
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254078 | HVT 2.0 | Vapotherm, Inc. | 2026-04-13 |
| K251448 | FL-10000U Respiratory Humidifier | Flexicare Medical Limited. | 2026-01-16 |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | 2026-01-14 |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | Fisher & Paykel Healthcare, Ltd. | 2025-12-19 |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small | Medline Industries, LP | 2025-07-02 |
| 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 Ca... | Fisher & Paykel Healthcare, Ltd. | 2025-06-25 |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | 2025-01-30 |
| K241778 | Hudson RCI Comfort Flo® CubCannula™ | Medline Industries, LP | 2024-12-19 |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | Medline Industries, LP | 2024-09-27 |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | Fisher & Paykel Healthcare, Ltd. | 2024-08-08 |
| K233707 | HFT150 | Invent Medical Corporation | 2024-06-14 |
| K233821 | F&P Optiflow Oxygen Kit (AA451J) | Fisher & Paykel Healthcare, Ltd. | 2024-06-13 |
| K222292 | F&P myAirvo 3 | Fisher & Paykel Healthcare | 2024-05-08 |
| K231956 | F&P Optiflow+ Duet Nasal Cannula | Fisher & Paykel Healthcare, Ltd. | 2024-02-07 |
| 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. | 2023-10-26 |
| K223863 | BONHAWA Respiratory Humidifier | Telesair, Inc. | 2023-10-13 |
| K223684 | F&P 820 Humidification System | Fisher & Paykel Healthcare, Ltd. | 2023-09-05 |
| K231380 | AirLife DuoTherm™ Humidification System | Vyaire Medical, Inc. | 2023-08-10 |
| K223551 | Sterile Water for Inhalation in 1L Flexoval ® bottles. | Hometa, Inc. | 2023-08-03 |
| K220703 | F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare | 2023-06-16 |
| K222197 | F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range | Fisher & Paykel Healthcare, Ltd. | 2023-04-06 |
| K222351 | inspired™ VHB20 Heated Humidifier | Vincent Healthcare Products Limited | 2022-12-21 |
| K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit | Fisher & Paykel Healthcare, Ltd. | 2022-04-22 |
| K211096 | Optiflow Oxygen Kit | Fisher & Paykel Healthcare, Ltd. | 2022-01-28 |
| K203357 | HVT 2.0 | Vapotherm, Inc. | 2021-08-25 |
| K201723 | F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling | Fisher & Paykel Healthcare, Ltd. | 2021-03-16 |
| K193411 | O2asis Personal Oxygen Humidifier | Perma Pure, LLC | 2020-11-12 |
| K191818 | F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) | Fisher & Paykel Healthcare, Ltd. | 2020-03-19 |
| K191010 | Palladium High Flow Therapy System | Vapotherm, Inc. | 2019-10-10 |
| K162553 | AirSpiral Heated Breathing Tube | Fisher & Paykel Healthcare | 2018-12-20 |
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| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07640140860749 | Monsoon III Laserjet 70 | Acutronic Medical Systems AG | 2023-01-20 |
| 09420012416179 | Fisher and Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 08717146000420 | Medisize® | Medisize B.V. | 2016-10-11 |
| 08717146061025 | Medisize® | Medisize B.V. | 2016-10-11 |
| 08717146000390 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000406 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000413 | Medisize® | Medisize B.V. | 2016-10-07 |
| 09420012401342 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-13 |
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| 09420012420701 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012416810 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012400604 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
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| 09420012402615 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012402523 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |