510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950116Substantially Equivalent

Therasteam Personal Steam Inhaler

Kaz, Inc., Washington, D.C. DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950116 is the FDA 510(k) clearance record for THERASTEAM PERSONAL STEAM INHALER, a class I device, cleared for Kaz, Inc. on under FDA product code KFZ (Humidifier, Non-Direct Patient Interface (Home-Use)). FDA records list one 510(k) clearance for Kaz, Inc. As of , FDA records show one recall naming K950116.

Clearance record

Decision date
Received
(30 days to decision)
Product code
KFZ Humidifier, Non-Direct Patient Interface (Home-Use)
Regulation
21 CFR 868.5460
Device class
Class I
Review panel
Anesthesiology
Applicant
Kaz, Inc. Columbia Sq., Washington, D.C. DC
510(k) summary
Summary
Third party review
No

Clearances, product code KFZ

Trailing 12 months

FDA records hold no clearances under product code KFZ in the trailing twelve months.

FDA records show no clearances under product code KFZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KFZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260