KFZ · Humidifier, Non-Direct Patient Interface (Home-Use)
Anesthesiology · 21 CFR 868.5460 · Class 1
Overview
| Product Code | KFZ |
|---|---|
| Device Name | Humidifier, Non-Direct Patient Interface (Home-Use) |
| Regulation | 21 CFR 868.5460 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A therapeutic humidifier for home use is a device that adds water vapor to breathing gases and that is intended for respiratory therapy or other medical purposes. The vapor produced by the device pervades the area surrounding the patient, who breathes the vapor during normal respiration.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Cleared Devices (20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950116 | THERASTEAM PERSONAL STEAM INHALER | Kaz, Inc. | Feb 10, 1995 | SESE |
| K915603 | VIROTHERM HUMIDIFIER | Virotherm Laboratory | Oct 22, 1992 | SESE |
| K894734 | RHINOTHERM ULTRA 2 | Twinmed Products, Inc. | Feb 16, 1990 | SESE |
| K871661 | WH150 ROOM HUMIDIFIER | Associated Mills, Inc. | Jun 15, 1987 | SESE |
| K871189 | SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380 | Sunbeam Appliance Service Co. | May 8, 1987 | SESE |
| K862919 | TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER | Transpirator Technologics, Inc. | Nov 7, 1986 | SESE |
| K862171 | MP-500 ELECTRONIC NEBULIZER | The Timeter Group | Jul 14, 1986 | SESE |
| K862042 | SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER | Associated Mills, Inc. | Jun 5, 1986 | SESE |
| K851220 | SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 | Northern Electric Co. Div. of Sunbeam Corp. | Sep 17, 1985 | SESE |
| K852283 | THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE | Thermix, Inc. | Jul 30, 1985 | SESE |
| K850711 | INHALATION THERAPY NEBULIZER DEVICE | Med USA | Jun 5, 1985 | SESE |
| K842275 | ULTRASONIC COOL SPRAY HUMIDIFIER | Sunbeam Corp. | Aug 14, 1984 | SESE |
| K840118 | RHINOTHERM | Ascot Pharmaceuticals, Inc. | Apr 13, 1984 | SESE |
| K831646 | SONIC MIST ULTRASONIC HUMIDIFIER | Douglas Products | Jul 12, 1983 | SESE |
| K830896 | HUMIDIFIER, WITH OR WITHOUT ADAPTER | Airlife, Inc. | Apr 18, 1983 | SESE |
| K811161 | HUMIDIFIER W/ OR W/OUT ADAPTOR | Airlife, Inc. | Jun 24, 1981 | SESE |
| K810335 | RESPIRIZER | Respirizer Co., Div. Campillary Systems, Inc. | Mar 20, 1981 | SESE |
| K790966 | ULTRASONIC HUMIDIFIER | Hankscraft Div. of Gerber Products Co. | Jun 11, 1979 | SESE |
| K781591 | NEBULIZER/HUMIDIFIER MODEL EH 147B | Mistogen Equipment Co. | Oct 16, 1978 | SESE |
| K760341 | HUMIDIFIER, ELECTRONIC (EH147) | Mistogen Equipment Co. | Aug 11, 1976 | SESE |
Top Applicants
- Mistogen Equipment Co. — 2 clearances
- Associated Mills, Inc. — 2 clearances
- Airlife, Inc. — 2 clearances
- Virotherm Laboratory — 1 clearance
- Twinmed Products, Inc. — 1 clearance
