510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K052074Substantially Equivalent

Jsz-Stat-Tree, and Jsz-Stat-or, Cleaning, Disinfecting and Storing Solutions; Jsz-Wet-Tree and Jsz-Wet-or, Wetting,

Szabocsik and Associates, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052074 is the FDA 510(k) clearance record for JSZ-STAT-TREE, AND JSZ-STAT-OR, CLEANING, DISINFECTING AND STORING SOLUTIONS; JSZ-WET-TREE AND JSZ-WET-OR, WETTING,, a class II device, cleared for Szabocsik and Associates on under FDA product code MRC (Products, Contact Lens Care, Rigid Gas Permeable). FDA records list 3 510(k) clearances for Szabocsik and Associates, from to . As of , FDA records show no recalls naming K052074.

Clearance record

Decision date
Received
(31 days to decision)
Product code
MRC Products, Contact Lens Care, Rigid Gas Permeable
Regulation
21 CFR 886.5918
Device class
Class II
Review panel
Ophthalmic
Applicant
Szabocsik and Associates 203 N.Wabash, Suite 1200, Chicago IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MRC

Trailing 12 months

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

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