FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Autoclave Indicator Tape; EO Indicator Tape
K Number: K241036
·
Decision Dec 17, 2024
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
1
Review Days
245
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Autoclave Indicator Tape; EO Indicator Tape
- K Number
- K241036
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jiangmen New Era External Use Drug Co., Ltd.
- Date Received
- April 16, 2024
- Decision Date
- December 17, 2024
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOJ), ordered by most recent decision date.
LF Process Indicator Tape for Steam Sterilization
FDA 510(k)
FDA Class 2
·General Hospital
SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)
FDA 510(k)
FDA Class 2
·General Hospital
DISINTEK PA Test Strips
FDA 510(k)
FDA Class 2
·General Hospital
Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118
FDA 510(k)
FDA Class 2
·General Hospital
VERIFY STEAM Integrating Indicator
FDA 510(k)
FDA Class 2
·General Hospital
Green Card Bowie-Dick Test (BD115)
FDA 510(k)
FDA Class 2
·General Hospital