FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LF Process Indicator Tape for Steam Sterilization
K Number: K260181
·
Decision Feb 20, 2026
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
1
Review Days
30
Basic Information
- Device Name
- LF Process Indicator Tape for Steam Sterilization
- K Number
- K260181
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intertape Polymer Group
- Date Received
- January 21, 2026
- Decision Date
- February 20, 2026
- Product Code
- JOJ
- 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | FDA class 2 | General Hospital |
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SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)
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