FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Celerity 20 HP Biological Indicator
K Number: K252680
·
Decision Sep 24, 2025
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
205
Applicant Total
204
Review Days
30
Basic Information
- Device Name
- Celerity 20 HP Biological Indicator
- K Number
- K252680
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STERIS Corporation
- Date Received
- August 25, 2025
- Decision Date
- September 24, 2025
- Product Code
- FRC
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRC | Indicator, Biological Sterilization Process | FDA class 2 | General Hospital |
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