Cleared Special

Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

K251048 · STERIS Corporation · General Hospital
May 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K251048 is an FDA 510(k) clearance for the Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118, 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 May 2, 2025, 29 days after receiving the submission on April 3, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K251048 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2025
Decision Date May 02, 2025
Days to Decision 29 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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