510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162758Substantially Equivalent

VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack

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

K162758 is the FDA 510(k) clearance record for VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack, a class II device, cleared for STERIS Corporation on under FDA product code JOJ (Indicator, Physical/Chemical Sterilization Process). FDA records list 227 510(k) clearances for STERIS Corporation, from to . As of , FDA records show one recall naming K162758.

Clearance record

Decision date
Received
(172 days to decision)
Product code
JOJ Indicator, Physical/Chemical Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
STERIS Corporation 5960 Heisley Rd., Mentor OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOJ

Trailing 12 months
3 clearances under product code JOJ in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JOJ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260