510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871189Substantially Equivalent

Sunbeam Dura-Vap Warm Steam Vaporizer Model 1380

Sunbeam Appliance Service Co., Downers Grove IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871189 is the FDA 510(k) clearance record for SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380, a class I device, cleared for Sunbeam Appliance Service Co. on under FDA product code KFZ (Humidifier, Non-Direct Patient Interface (Home-Use)). FDA records list one 510(k) clearance for Sunbeam Appliance Service Co. As of , FDA records show no recalls naming K871189.

Clearance record

Decision date
Received
(45 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
Sunbeam Appliance Service Co. P.O. Box 1570, Downers Grove IL
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