K230558 is an FDA 510(k) clearance for the Revital-Ox PAA High Level Disinfectant Chemical Indicator. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on July 17, 2023, 139 days after receiving the submission on February 28, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K230558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2023 |
| Decision Date | July 17, 2023 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JOJ — Indicator, Physical/chemical Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |