FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Chex-All Sterilization Pouches and Tubes
K Number: K250306
·
Decision Oct 31, 2025
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
7
Review Days
270
Basic Information
- Device Name
- Chex-All Sterilization Pouches and Tubes
- K Number
- K250306
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Propper Manufacturing Co., Inc.
- Date Received
- February 3, 2025
- Decision Date
- October 31, 2025
- Product Code
- FRG
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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Other Clearances by Propper Manufacturing Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240910 | EO Chex Indicator Tape | Jun 12, 2024 | Substantially Equivalent |
| K222137 | OK Plus Indicator | Dec 5, 2022 | Substantially Equivalent |
| K212592 | Gas-Chex Indicator | Jan 20, 2022 | Substantially Equivalent |
| K210866 | Steri-Dot Process Indicator | Jun 21, 2021 | Substantially Equivalent |
| K210553 | Steam-Dot Process Indicator | May 19, 2021 | Substantially Equivalent |
| K141638 | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | Sep 17, 2014 | Substantially Equivalent |