510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230085Unknown

VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator

STERIS Corporation, Mentor OH / Direct, Unknown
FDA source (opens on fda.gov)

DEN230085 is the FDA 510(k) clearance record for VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator, a class II device, cleared for Steris on under FDA product code SDC (Qualitative Cleaning Process Protein Indicator). FDA's definition for product code SDC reads: "A qualitative cleaning process protein indicator is intended for use by a health care provider on a cleaned medical device as an interim step prior to high level disinfection or sterilization of the cleaned medical device. The intended use...". FDA records list 227 510(k) clearances for Steris, from to . As of , FDA records show no recalls naming DEN230085.

Clearance record

Decision date
Received
(330 days to decision)
Product code
SDC Qualitative Cleaning Process Protein Indicator
Regulation
21 CFR 880.6930
Device class
Class II
Review panel
General Hospital
Applicant
Steris 5960 Heisley Rd., Mentor OH
Third party review
No

Clearances, product code SDC

Trailing 12 months

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

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