K243501 is an FDA 510(k) clearance for the 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE. This device is classified as a Indicator, Biological Sterilization Process (Class II - Special Controls, product code FRC).
Submitted by 3M Company (St. Paul, US). The FDA issued a Cleared decision on January 28, 2025, 77 days after receiving the submission on November 12, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K243501 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2024 |
| Decision Date | January 28, 2025 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.2800 |