510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203223Substantially Equivalent

Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide

STERIS Corporation, Mentor OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203223 is the FDA 510(k) clearance record for Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide, a class II device, cleared for Steris on under FDA product code NZA (Accessories, Germicide, Cleaning, For Endoscopes). FDA's definition for product code NZA reads: "High level disinfection of reusable, heat-sensitive devices If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807...". FDA records list 227 510(k) clearances for Steris, from to . As of , FDA records show no recalls naming K203223.

Clearance record

Decision date
Received
(87 days to decision)
Product code
NZA Accessories, Germicide, Cleaning, For Endoscopes
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Steris 5960 Heisley Rd., Mentor OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NZA

Trailing 12 months

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

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