510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904469Substantially Equivalent

Eyeopener

Kc Medical Industries, Oshkosh WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904469 is the FDA 510(k) clearance record for EYEOPENER, a class I device, cleared for Kc Medical Industries on under FDA product code JYJ (Gauge, Measuring). FDA records list one 510(k) clearance for Kc Medical Industries. As of , FDA records show no recalls naming K904469.

Clearance record

Decision date
Received
(270 days to decision)
Product code
JYJ Gauge, Measuring
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Kc Medical Industries 509 S. Washburn St., Oshkosh WI
Third party review
No

Clearances, product code JYJ

Trailing 12 months

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

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