510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884922Substantially Equivalent

The Breathe Ease Nursery Vapor Tent

Cal-Trends Products, Fullerton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884922 is the FDA 510(k) clearance record for THE BREATHE EASE NURSERY VAPOR TENT, a class II device, cleared for Cal-Trends Products on under FDA product code FNC (Tent, Pediatric Aerosol). FDA records list one 510(k) clearance for Cal-Trends Products. As of , FDA records show no recalls naming K884922.

Clearance record

Decision date
Received
(67 days to decision)
Product code
FNC Tent, Pediatric Aerosol
Regulation
21 CFR 868.5710
Device class
Class II
Review panel
Anesthesiology
Applicant
Cal-Trends Products 825 N. Harbor Blvd., Fullerton CA
Third party review
No

Clearances, product code FNC

Trailing 12 months

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

FDA records show no clearances under product code FNC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FNC, 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