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)

K251452 · Steris · General Hospital
Jun 2025
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K251452 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 (Mentor, US). The FDA issued a Cleared decision on June 6, 2025, 28 days after receiving the submission on May 9, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K251452 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2025
Decision Date June 06, 2025
Days to Decision 28 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
Celerity? 20 HP Biological Indicator
K252680 · STERIS Corporation · Sep 2025
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)
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