K221474 is an FDA 510(k) clearance for the PRIMUS Healthcare Sterilizer (Model PSS11-HC). This device is classified as a Sterilizer, Steam (Class II - Special Controls, product code FLE).
Submitted by Primus Sterilizer Company, LLC (Orlando, US). The FDA issued a Cleared decision on February 10, 2023, 266 days after receiving the submission on May 20, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6880.
| 510(k) Number | K221474 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2022 |
| Decision Date | February 10, 2023 |
| Days to Decision | 266 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FLE - Sterilizer, Steam |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6880 |