510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841589Substantially Equivalent

C-Lite

Suncoast Medical Manufacturers, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841589 is the FDA 510(k) clearance record for C-LITE, a class I device, cleared for Suncoast Medical Manufacturers, Inc. on under FDA product code KYT (Light, Examination, Medical, Battery Powered). FDA records list 31 510(k) clearances for Suncoast Medical Manufacturers, Inc., from to . As of , FDA records show no recalls naming K841589.

Clearance record

Decision date
Received
(34 days to decision)
Product code
KYT Light, Examination, Medical, Battery Powered
Regulation
21 CFR 880.6350
Device class
Class I
Review panel
General Hospital
Applicant
Suncoast Medical Manufacturers, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KYT

Trailing 12 months

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

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