510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K953042Substantially Equivalent

E-Z Breathers

E-Z Kare Good Health Systems, Inc., Tavares FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953042 is the FDA 510(k) clearance record for E-Z BREATHERS, a class I device, cleared for E-Z Kare Good Health Systems, Inc. on under FDA product code LWF (Dilator, Nasal). FDA records list one 510(k) clearance for E-Z Kare Good Health Systems, Inc. As of , FDA records show no recalls naming K953042.

Clearance record

Decision date
Received
(176 days to decision)
Product code
LWF Dilator, Nasal
Regulation
21 CFR 874.3900
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
E-Z Kare Good Health Systems, Inc. P.O. Box 11, Tavares FL
510(k) summary
Statement
Third party review
No

Clearances, product code LWF

Trailing 12 months

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

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