510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831646Substantially Equivalent

Sonic Mist Ultrasonic Humidifier

Douglas Products, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831646 is the FDA 510(k) clearance record for SONIC MIST ULTRASONIC HUMIDIFIER, a class I device, cleared for Douglas Products on under FDA product code KFZ (Humidifier, Non-Direct Patient Interface (Home-Use)). FDA records list one 510(k) clearance for Douglas Products. As of , FDA records show no recalls naming K831646.

Clearance record

Decision date
Received
(54 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
Douglas Products 4221 Richmond Rd., NW, Walker MI
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