K241959 is an FDA 510(k) clearance for the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD). 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 October 18, 2024, 107 days after receiving the submission on July 3, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800.
| 510(k) Number | K241959 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2024 |
| Decision Date | October 18, 2024 |
| Days to Decision | 107 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 |