510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812201Substantially Equivalent

Photographic Equipment

Reznik Instruments, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812201 is the FDA 510(k) clearance record for PHOTOGRAPHIC EQUIPMENT, a class I device, cleared for Reznik Instruments on under FDA product code FEM (Accessories, Photographic, For Endoscope (Exclude Light Sources)). FDA records list 9 510(k) clearances for Reznik Instruments, from to . As of , FDA records show no recalls naming K812201.

Clearance record

Decision date
Received
(76 days to decision)
Product code
FEM Accessories, Photographic, For Endoscope (Exclude Light Sources)
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Reznik Instruments 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FEM

Trailing 12 months

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

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