Humidifier, Non-Direct Patient Interface (Home-Use)
Non-Direct Patient Interface Home-Use Humidifier is a respiratory therapy device intended for home use that adds moisture to the breathing environment without direct patient contact, helping to prevent drying of the airways in patients receiving supplemental oxygen or other respiratory therapy at home. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KFZ, regulated under 21 CFR 868.5460, within the Anesthesiology medical specialty.
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Basic Information
- Product Code
- KFZ
- Device Class
- FDA class 1
- Regulation Number
- 868.5460
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 20 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K950116 | THERASTEAM PERSONAL STEAM INHALER | Feb 10, 1995 | Substantially Equivalent | Kaz, Inc. |
| K915603 | VIROTHERM HUMIDIFIER | Oct 22, 1992 | Substantially Equivalent | Virotherm Laboratory |
| K894734 | RHINOTHERM ULTRA 2 | Feb 16, 1990 | Substantially Equivalent | Twinmed Products, Inc. |
| K871661 | WH150 ROOM HUMIDIFIER | Jun 15, 1987 | Substantially Equivalent | Associated Mills, Inc. |
| K871189 | SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380 | May 08, 1987 | Substantially Equivalent | Sunbeam Appliance Service Co. |
| K862919 | TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER | Nov 07, 1986 | Substantially Equivalent | Transpirator Technologics, Inc. |
| K862171 | MP-500 ELECTRONIC NEBULIZER | Jul 14, 1986 | Substantially Equivalent | The Timeter Group |
| K862042 | SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER | Jun 05, 1986 | Substantially Equivalent | Associated Mills, Inc. |
| K851220 | SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 | Sep 17, 1985 | Substantially Equivalent | Northern Electric Co. Div. of Sunbeam Corp. |
| K852283 | THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE | Jul 30, 1985 | Substantially Equivalent | Thermix, Inc. |
| K850711 | INHALATION THERAPY NEBULIZER DEVICE | Jun 05, 1985 | Substantially Equivalent | Med USA |
| K842275 | ULTRASONIC COOL SPRAY HUMIDIFIER | Aug 14, 1984 | Substantially Equivalent | Sunbeam Corp. |
| K840118 | RHINOTHERM | Apr 13, 1984 | Substantially Equivalent | Ascot Pharmaceuticals, Inc. |
| K831646 | SONIC MIST ULTRASONIC HUMIDIFIER | Jul 12, 1983 | Substantially Equivalent | Douglas Products |
| K830896 | HUMIDIFIER, WITH OR WITHOUT ADAPTER | Apr 18, 1983 | Substantially Equivalent | Airlife, Inc. |
| K811161 | HUMIDIFIER W/ OR W/OUT ADAPTOR | Jun 24, 1981 | Substantially Equivalent | Airlife, Inc. |
| K810335 | RESPIRIZER | Mar 20, 1981 | Substantially Equivalent | Respirizer Co., Div. Campillary Systems, Inc. |
| K790966 | ULTRASONIC HUMIDIFIER | Jun 11, 1979 | Substantially Equivalent | Hankscraft Div. of Gerber Products Co. |
| K781591 | NEBULIZER/HUMIDIFIER MODEL EH 147B | Oct 16, 1978 | Substantially Equivalent | Mistogen Equipment Co. |
| K760341 | HUMIDIFIER, ELECTRONIC (EH147) | Aug 11, 1976 | Substantially Equivalent | Mistogen Equipment Co. |
FEI Numbers
This FDA classification entry is associated with 119 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 119 registration numbers. Click on an entry to view related FDA registrations.