510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K904659Substantially Equivalent

Dr. Dedo's Family Ear Examination Kit

Panex Corp., North Palm Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904659 is the FDA 510(k) clearance record for DR. DEDO'S FAMILY EAR EXAMINATION KIT, a class I device, cleared for Panex Corp. on under FDA product code ERA (Otoscope). FDA records list one 510(k) clearance for Panex Corp. As of , FDA records show no recalls naming K904659.

Clearance record

Decision date
Received
(197 days to decision)
Product code
ERA Otoscope
Regulation
21 CFR 874.4770
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Panex Corp. 631 U.S. Hwy. One, North Palm Beach FL
Third party review
No

Clearances, product code ERA

Trailing 12 months

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

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