FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
K Number: K251452
·
Decision Jun 6, 2025
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
205
Applicant Total
21
Review Days
28
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Basic Information
- Device Name
- Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
- K Number
- K251452
- 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
- Date Received
- May 9, 2025
- Decision Date
- June 6, 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FRC), ordered by most recent decision date.
Celerity 5 HP Biological Indicator (LCB052)
FDA 510(k)
FDA Class 2
·General Hospital
Celerity 20 HP Biological Indicator
FDA 510(k)
FDA Class 2
·General Hospital
Terragene® Bionova® BT20 Biological Indicator
FDA 510(k)
FDA Class 2
·General Hospital
Celerity Incubator
FDA 510(k)
FDA Class 2
·General Hospital
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
FDA 510(k)
FDA Class 2
·General Hospital
3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest Auto-reader 490; 3M Attest Auto-reader 490H; 3M Attest Mini Auto-reader 490M
FDA 510(k)
FDA Class 2
·General Hospital
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