Submission Details
| 510(k) Number | K243501 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
3M? Attest? Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M? Attest? Auto-reader 490; 3M? Attest? Auto-reader 490H; 3M? Attest? Mini Auto-reader 490M
Jan 2025
Decision
77d
Days
Class 2
Risk
About This 510(k) Submission
K243501 is an FDA 510(k) clearance for the 3M? Attest? Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M? Attest? Auto-reader 490; 3M? Attest? Auto-reader 490H; 3M? Attest? Mini Auto-reader 490M, 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 review panel. Regulated under 21 CFR 880.2800.
Device Classification
| Product Code | FRC — Indicator, Biological Sterilization Process |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2800 |
Manufacturer
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