Atlas FDA

KFZ

20 FDA 510(k) clearances · Product code

54 daysmedian time to decision
207 days90th percentile
20clearances measured

FDA profile

Official device name
Humidifier, Non-Direct Patient Interface (Home-Use)
Device class
Class I (low risk)
Regulation
21 CFR 868.5460
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2018: 59 · 2019: 41 · 2020: 32 · 2021: 32 · 2022: 24 · 2023: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
THERASTEAM PERSONAL STEAM INHALER (K950116)Kaz, Inc.1995-02-10
VIROTHERM HUMIDIFIER (K915603)Virotherm Laboratory1992-10-22
RHINOTHERM ULTRA 2 (K894734)Twinmed Products, Inc.1990-02-16
WH150 ROOM HUMIDIFIER (K871661)Associated Mills, Inc.1987-06-15
SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380 (K871189)Sunbeam Appliance Service Co.1987-05-08
TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER (K862919)Transpirator Technologics, Inc.1986-11-07
MP-500 ELECTRONIC NEBULIZER (K862171)The Timeter Group1986-07-14
SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER (K862042)Associated Mills, Inc.1986-06-05
SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664 (K851220)Northern Electric Co. Div. of Sunbeam Corp.1985-09-17
THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE (K852283)Thermix, Inc.1985-07-30
INHALATION THERAPY NEBULIZER DEVICE (K850711)Med USA1985-06-05
ULTRASONIC COOL SPRAY HUMIDIFIER (K842275)Sunbeam Corp.1984-08-14
RHINOTHERM (K840118)Ascot Pharmaceuticals, Inc.1984-04-13
SONIC MIST ULTRASONIC HUMIDIFIER (K831646)Douglas Products1983-07-12
HUMIDIFIER, WITH OR WITHOUT ADAPTER (K830896)Airlife, Inc.1983-04-18
HUMIDIFIER W/ OR W/OUT ADAPTOR (K811161)Airlife, Inc.1981-06-24
RESPIRIZER (K810335)Respirizer Co., Div. Campillary Systems, Inc.1981-03-20
ULTRASONIC HUMIDIFIER (K790966)Hankscraft Div. of Gerber Products Co.1979-06-11
NEBULIZER/HUMIDIFIER MODEL EH 147B (K781591)Mistogen Equipment Co.1978-10-16
HUMIDIFIER, ELECTRONIC (EH147) (K760341)Mistogen Equipment Co.1976-08-11

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Every clearance here is in the API, with alerts when new ones post.