510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K882564Substantially Equivalent

Renalin Cold Sterilant

Medivators Inc, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882564 is the FDA 510(k) clearance record for RENALIN COLD STERILANT, a class I device, cleared for Minntech Corp. on under FDA product code LRJ (Disinfectant, Medical Devices). FDA records list 46 510(k) clearances for Medivators Inc, from to . As of , FDA records show no recalls naming K882564.

Clearance record

Decision date
Received
(202 days to decision)
Product code
LRJ Disinfectant, Medical Devices
Regulation
21 CFR 880.6890
Device class
Class I
Review panel
General Hospital
Applicant
Minntech Corp. 14905 28th Ave. N., Minneapolis MN
Third party review
No

Clearances, product code LRJ

Trailing 12 months

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

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