Cleared Special

Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)

K250044 · STERIS Corporation · General Hospital
Feb 2025
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K250044 is an FDA 510(k) clearance for the Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045), a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on February 6, 2025, 27 days after receiving the submission on January 10, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K250044 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 2025
Decision Date February 06, 2025
Days to Decision 27 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRC — Indicator, Biological Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

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