Product code KFZ
- Device name
- Humidifier, Non-Direct Patient Interface (Home-Use)
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5460
- 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 |
|---|---|---|---|
| K950116 | THERASTEAM PERSONAL STEAM INHALER | Kaz, Inc. | 1995-02-10 |
| K915603 | VIROTHERM HUMIDIFIER | Virotherm Laboratory | 1992-10-22 |
| K894734 | RHINOTHERM ULTRA 2 | Twinmed Products, Inc. | 1990-02-16 |
| K871661 | WH150 ROOM HUMIDIFIER | Associated Mills, Inc. | 1987-06-15 |
| K871189 | SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380 | Sunbeam Appliance Service Co. | 1987-05-08 |
| K862919 | TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER | Transpirator Technologics, Inc. | 1986-11-07 |
| K862171 | MP-500 ELECTRONIC NEBULIZER | The Timeter Group | 1986-07-14 |
| K862042 | SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER | Associated Mills, Inc. | 1986-06-05 |
| K851220 | SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 | Northern Electric Co. Div. of Sunbeam Corp. | 1985-09-17 |
| K852283 | THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE | Thermix, Inc. | 1985-07-30 |
| K850711 | INHALATION THERAPY NEBULIZER DEVICE | Med USA | 1985-06-05 |
| K842275 | ULTRASONIC COOL SPRAY HUMIDIFIER | Sunbeam Corp. | 1984-08-14 |
| K840118 | RHINOTHERM | Ascot Pharmaceuticals, Inc. | 1984-04-13 |
| K831646 | SONIC MIST ULTRASONIC HUMIDIFIER | Douglas Products | 1983-07-12 |
| K830896 | HUMIDIFIER, WITH OR WITHOUT ADAPTER | Airlife, Inc. | 1983-04-18 |
| K811161 | HUMIDIFIER W/ OR W/OUT ADAPTOR | Airlife, Inc. | 1981-06-24 |
| K810335 | RESPIRIZER | Respirizer Co., Div. Campillary Systems, Inc. | 1981-03-20 |
| K790966 | ULTRASONIC HUMIDIFIER | Hankscraft Div. of Gerber Products Co. | 1979-06-11 |
| K781591 | NEBULIZER/HUMIDIFIER MODEL EH 147B | Mistogen Equipment Co. | 1978-10-16 |
| K760341 | HUMIDIFIER, ELECTRONIC (EH147) | Mistogen Equipment Co. | 1976-08-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06971156891849 | Equate | WAL-MART STORES, INC. | 2026-07-31 |
| 04719874957315 | Create Biotech | CREATE BIOTECH CO., LTD. | 2026-07-21 |
| 10889483229422 | AirLife™ | SUNMED, LLC | 2025-12-19 |
| 10889483054338 | AirLife™ | SUNMED, LLC | 2025-12-19 |
| 10889483054321 | AirLife™ | SUNMED, LLC | 2025-12-18 |
| 00851440007711 | Responsive Respiratory | RESPONSIVE RESPIRATORY, INC. | 2024-08-01 |
| 00851440007704 | Responsive Respiratory | RESPONSIVE RESPIRATORY, INC. | 2024-08-01 |
| 04719872103028 | Bubble Humidifier | ENTER MEDICAL CORPORATION | 2023-10-19 |
| 10840330700273 | Procure | Twin Med, LLC | 2022-11-02 |
| 10840330700266 | Procure | Twin Med, LLC | 2022-11-02 |
| 10840330700259 | Procure | Twin Med, LLC | 2022-11-02 |
| 00840117308855 | Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL | Dynarex Corporation | 2022-05-11 |
| 00709078014277 | Bubble Humidifier | WESTMED, INC. | 2022-03-31 |
| 00709078014284 | Bubble Humidifier | WESTMED, INC. | 2022-03-31 |
| 00709078014093 | Bubble Humidifier | WESTMED, INC. | 2022-03-31 |
| 00709078007606 | Bubble Humidifier | WESTMED, INC. | 2021-02-24 |
| 20612479203710 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-07-21 |
| 00011822781930 | Rite Aid Pharmacy | RITE AID CORPORATION | 2020-05-21 |
| 50822383116483 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |
| 50822383527982 | DRIVEMEDICAL | Drive Devilbiss Healthcare | 2019-06-21 |
| 00850005614067 | NanoVi | ENG3 CORPORATION | 2019-02-25 |
| 00850005614043 | NanoVi | ENG3 CORPORATION | 2019-02-25 |
| 00850005614029 | NanoVi | ENG3 CORPORATION | 2019-02-25 |
| 00709078005954 | OxyGo Bubble Humidifier | WESTMED, INC. | 2018-09-25 |
| 00848530060732 | Bubble Humidifiers - 6psi | SUNSET HEALTHCARE SOLUTIONS, INC. | 2018-07-31 |
| 00709078003899 | Composite Kit | WESTMED, INC. | 2017-05-26 |
| 00709078003868 | Humidifier Adaptor | WESTMED, INC. | 2017-05-26 |
| 00709078003158 | Bubble Humidifier | WESTMED, INC. | 2017-04-26 |
| 00709078003028 | Composite Kit | WESTMED, INC. | 2017-04-26 |
| 00709078003011 | Composite Kit | WESTMED, INC. | 2017-04-26 |