Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

KFZ — Predicate Candidate Screening

20 FDA 510(k) clearances under this product code; the 50 most recent screened below.

54 daysmedian FDA review time

207 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days
K950116	THERASTEAM PERSONAL STEAM INHALER	Kaz, Inc.	1995-02-10	30
K915603	VIROTHERM HUMIDIFIER	Virotherm Laboratory	1992-10-22	311
K894734	RHINOTHERM ULTRA 2	Twinmed Products, Inc.	1990-02-16	207
K871661	WH150 ROOM HUMIDIFIER	Associated Mills, Inc.	1987-06-15	48
K871189	SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380	Sunbeam Appliance Service Co.	1987-05-08	45
K862919	TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER	Transpirator Technologics, Inc.	1986-11-07	98
K862171	MP-500 ELECTRONIC NEBULIZER	The Timeter Group	1986-07-14	35
K862042	SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER	Associated Mills, Inc.	1986-06-05	8
K851220	SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664	Northern Electric Co. Div. of Sunbeam Corp.	1985-09-17	175
K852283	THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE	Thermix, Inc.	1985-07-30	62
K850711	INHALATION THERAPY NEBULIZER DEVICE	Med USA	1985-06-05	103
K842275	ULTRASONIC COOL SPRAY HUMIDIFIER	Sunbeam Corp.	1984-08-14	67
K840118	RHINOTHERM	Ascot Pharmaceuticals, Inc.	1984-04-13	93
K831646	SONIC MIST ULTRASONIC HUMIDIFIER	Douglas Products	1983-07-12	54
K830896	HUMIDIFIER, WITH OR WITHOUT ADAPTER	Airlife, Inc.	1983-04-18	28
K811161	HUMIDIFIER W/ OR W/OUT ADAPTOR	Airlife, Inc.	1981-06-24	57
K810335	RESPIRIZER	Respirizer Co., Div. Campillary Systems, Inc.	1981-03-20	39
K790966	ULTRASONIC HUMIDIFIER	Hankscraft Div. of Gerber Products Co.	1979-06-11	20
K781591	NEBULIZER/HUMIDIFIER MODEL EH 147B	Mistogen Equipment Co.	1978-10-16	28
K760341	HUMIDIFIER, ELECTRONIC (EH147)	Mistogen Equipment Co.	1976-08-11	12

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda