510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954184Substantially Equivalent

Jed-Light Fiberoptic Light Source

JEDMED Instrument Company, Saint Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954184 is the FDA 510(k) clearance record for JED-LIGHT FIBEROPTIC LIGHT SOURCE, a class I device, cleared for Jedmed Instrument Co. on under FDA product code EQH (Source, Carrier, Fiberoptic Light). FDA records list 93 510(k) clearances for Jedmed Instrument Co., from to . As of , FDA records show no recalls naming K954184.

Clearance record

Decision date
Received
(68 days to decision)
Product code
EQH Source, Carrier, Fiberoptic Light
Regulation
21 CFR 874.4350
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Jedmed Instrument Co. 5416 Jedmed Ct., Saint Louis MO
510(k) summary
Statement
Third party review
No

Clearances, product code EQH

Trailing 12 months

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

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