Celerity 5 HP Biological Indicator (LCB052)— 510(k) K260766
Substantially EquivalentSTERIS Corporation
FDA 510(k) clearance K260766 for Celerity 5 HP Biological Indicator (LCB052), Substantially Equivalent on 2026-04-08. Applicant: STERIS Corporation. Device class: 2.
Summary
STERIS Corporation's Celerity 5 HP Biological Indicator (LCB052) is filed under product code FRC (Indicator, Biological Sterilization Process).
Class II, 21 CFR 880.2800. General Hospital is both the classification panel and the review panel, and it came in as a Special 510(k).
STERIS filed from Mentor, Ohio. The decision came 30 calendar days after FDA received it (March 9 to April 8, 2026).
Clearance details
- Applicant
- STERIS Corporation
- Product code
- Product code FRC
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mentor, OH, US
Recent devices under product code FRC
view allMore clearances from STERIS Corporation
view allData sourced from openFDA. This site is unofficial and independent of the FDA.