Cleared Special

VERIFY STEAM Integrating Indicator

K243876 · STERIS Corporation · General Hospital
Apr 2025
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K243876 is an FDA 510(k) clearance for the VERIFY STEAM Integrating Indicator, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on April 25, 2025, 128 days after receiving the submission on December 18, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K243876 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2024
Decision Date April 25, 2025
Days to Decision 128 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code JOJ — Indicator, Physical/chemical Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

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