Cleared Special

Celerity? 20 HP Biological Indicator

K252680 · STERIS Corporation · General Hospital
Sep 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K252680 is an FDA 510(k) clearance for the Celerity? 20 HP Biological Indicator, 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 September 24, 2025, 30 days after receiving the submission on August 25, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K252680 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2025
Decision Date September 24, 2025
Days to Decision 30 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

Similar Devices — FRC Indicator, Biological Sterilization Process

All 204
Terragene? Bionova? BT20 Biological Indicator
K251122 · Terragene · Aug 2025
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
K251452 · Steris · Jun 2025
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 · Feb 2025
Celerity Incubator
K250061 · STERIS Corporation · Feb 2025
3M? Attest? Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M? Attest? Auto-reader 490; 3M? Attest? Auto-reader 490H; 3M? Attest? Mini Auto-reader 490M
K243501 · 3M Company · Jan 2025
Terragene? Bionova? Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene? Bionova? Photon Process Challenge Device with moving-front integrator (PCD225-C)
K242453 · Terragene S.A. · Dec 2024

More from STERIS Corporation

View all
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
K251048 · JOJ · May 2025
VERIFY STEAM Integrating Indicator
K243876 · JOJ · Apr 2025
PADLOCK CLIP EFTR Kit (00713229)
K250842 · PKL · Apr 2025
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 · FRC · Feb 2025
Celerity Incubator
K250061 · FRC · Feb 2025