510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864801Substantially Equivalent

The Keymed Hi-Light 250 Light Source

Keymed, Inc., Essex Ss2 5qh England, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864801 is the FDA 510(k) clearance record for THE KEYMED HI-LIGHT 250 LIGHT SOURCE, a class II device, cleared for Keymed, Inc. on under FDA product code GCT (Light Source, Endoscope, Xenon Arc). FDA records list 29 510(k) clearances for Keymed, Inc., from to . As of , FDA records show no recalls naming K864801.

Clearance record

Decision date
Received
(15 days to decision)
Product code
GCT Light Source, Endoscope, Xenon Arc
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Keymed, Inc. Keymed House, Stock Rd., Essex Ss2 5qh England, GB
Third party review
No

Clearances, product code GCT

Trailing 12 months

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

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