Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Celerity 5 HP Biological Indicator (LCB052)

K-Number: K260766 · 2026-04-08

ApplicantSTERIS Corporation
Decision Date2026-04-08
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Celerity 5 HP Biological Indicator (LCB052) is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2026-04-08 under approval number K260766. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Celerity 5 HP Biological Indicator (LCB052)?

Celerity 5 HP Biological Indicator (LCB052) is a medical device that received FDA 510(k) clearance on 2026-04-08. It is manufactured by STERIS Corporation. The 510(k) number is K260766.

When was Celerity 5 HP Biological Indicator (LCB052) approved by the FDA?

Celerity 5 HP Biological Indicator (LCB052) received FDA 510(k) clearance on 2026-04-08, under approval number K260766.

What company makes Celerity 5 HP Biological Indicator (LCB052)?

Celerity 5 HP Biological Indicator (LCB052) is manufactured by STERIS Corporation.

What is the FDA product code for Celerity 5 HP Biological Indicator (LCB052)?

The FDA product code for Celerity 5 HP Biological Indicator (LCB052) is FRC.

Other Devices by STERIS Corporation

K160912Sterilization Tray K161683SYSTEM 1E Liquid Chemical Sterilant Processing System K160908Vis-U-All Low Temperature Sterilization Pouch/Tubing K160433V-PRO® 1 Plus and V-PRO® maX Low Temperature K160485VERIFY VH2O2 Indicator Tape K152630VERIFY STEAM Integrating Indicator

View all 119 devices →

Related Devices (Code: FRC)

K1605463M Attest Rapid Readout Biological Indicator3M Company K151482BCR-30-min BI™ and RBIP-ST30™ Readout AccessoryBcr Diagnostics, Inc. K172474Celerity 20 HP Biological IndicatorSTERIS Corporation K172432SporView Rapid Read Biological IndicatorCrosstex/Spsmedical, A Division of Cantel Medical K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorTerragene S.A. K170427Anprolene SteriTestAndersen Sterilizers, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑