510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983068Substantially Equivalent

Reliance Family of Washer-Disinfectors

STERIS Corporation, Mentor OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983068 is the FDA 510(k) clearance record for RELIANCE FAMILY OF WASHER-DISINFECTORS, a class II device, cleared for STERIS Corporation on under FDA product code LDS (Device, Pasteurization, Hot Water). FDA records list 227 510(k) clearances for STERIS Corporation, from to . As of , FDA records show no recalls naming K983068.

Clearance record

Decision date
Received
(637 days to decision)
Product code
LDS Device, Pasteurization, Hot Water
Regulation
21 CFR 880.6991
Device class
Class II
Review panel
General Hospital
Applicant
STERIS Corporation 5960 Heisley Rd., Mentor OH
510(k) summary
Summary
Third party review
No

Clearances, product code LDS

Trailing 12 months

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

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