K252680
- 510(k) number
- K252680
- Device name
- Celerity 20 HP Biological Indicator
- Applicant
- STERIS Corporation OH · US
- Product code
- FRC — Indicator, Biological Sterilization Process
- Decision date
- 2025-09-24
- Date received
- 2025-08-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252680.pdf
Official FDA record: K252680
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.