510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011031Substantially Equivalent

Vysis Urovysion Bladder Cancer Recurrence Kit

Vysis, Downers Grove IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011031 is the FDA 510(k) clearance record for VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT, a class II device, cleared for Vysis on under FDA product code MMW (System, Test, Tumor Marker, Monitoring, Bladder). FDA records list 9 510(k) clearances for Vysis, from to . As of , FDA records show one recall naming K011031.

Clearance record

Decision date
Received
(120 days to decision)
Product code
MMW System, Test, Tumor Marker, Monitoring, Bladder
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Vysis 3100 Woodcreek Dr., Downers Grove IL
510(k) summary
Summary
Third party review
No

Clearances, product code MMW

Trailing 12 months

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

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