Cleared Traditional

Type 5 Integrating Indicator for Steam (CSPN-15)

K242860 · True Indicating, LLC · General Hospital
Jan 2025
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K242860 is an FDA 510(k) clearance for the Type 5 Integrating Indicator for Steam (CSPN-15), a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by True Indicating, LLC (Toledo, US). The FDA issued a Cleared decision on January 17, 2025, 119 days after receiving the submission on September 20, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K242860 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2024
Decision Date January 17, 2025
Days to Decision 119 days
Submission Type Traditional
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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