Celerity 5 HP Biological Indicator (LCB052) +3 more— 510(k) K251452

Name: FDA 510(k) clearance K251452
Creator: U.S. Food and Drug Administration
Published: 2025-06-06

Substantially Equivalent

Steris

FDA 510(k) clearance K251452 for Celerity 5 HP Biological Indicator (LCB052) +3 more, Substantially Equivalent on 2025-06-06. Applicant: Steris. Device class: 2.

Clearance details

Device name as filed: Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
Applicant: Steris
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2025-05-09
Decision date: 2025-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRC

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K260766 — Celerity 5 HP Biological Indicator (LCB052)2026-04-08
K252680 — Celerity 20 HP Biological Indicator2025-09-24
K251122 — Terragene® Bionova® BT20 Biological Indicator2025-08-04
K250044 — Celerity 5 HP Biological Indicator (LCB052) +3 more2025-02-06
K250061 — Celerity Incubator2025-02-06

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Data sourced from openFDA. This site is unofficial and independent of the FDA.