510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K904871Substantially Equivalent

Medi-Kleer

North American Marketing Corp., Santa Ynez CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904871 is the FDA 510(k) clearance record for MEDI-KLEER, a class II device, cleared for North American Marketing Corp. on under FDA product code OCT (Anti Fog Solution And Accessories, Endoscopy). FDA's definition for product code OCT reads: "To prevent, reduce or eliminate condensation (fog) on endoscopic lens". FDA records list one 510(k) clearance for North American Marketing Corp. As of , FDA records show no recalls naming K904871.

Clearance record

Decision date
Received
(323 days to decision)
Product code
OCT Anti Fog Solution And Accessories, Endoscopy
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
North American Marketing Corp. P.O. Box 1029, Santa Ynez CA
Third party review
No

Clearances, product code OCT

Trailing 12 months

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

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