K210866 is an FDA 510(k) clearance for the Steri-Dot Process 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 June 21, 2021, 90 days after receiving the submission on March 23, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K210866 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 2021 |
| Decision Date | June 21, 2021 |
| Days to Decision | 90 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 |