K222137 is an FDA 510(k) clearance for the OK Plus Indicator. This device is classified as a Indicator, Physical/chemical Sterilization Process (Class II - Special Controls, product code JOJ).
Submitted by Propper Manufacturing Co., Inc. (Long Island, US). The FDA issued a Cleared decision on December 5, 2022, 139 days after receiving the submission on July 19, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K222137 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2022 |
| Decision Date | December 05, 2022 |
| Days to Decision | 139 days |
| Submission Type | Abbreviated |
| 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 |