Submission Details
| 510(k) Number | K241959 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
3M? Attest? Super Rapid Steam Clear Challenge Pack (1492PCD); 3M? Attest? Auto-reader (490); 3M? Attest? Auto-reader (490H); 3M? Attest? Mini Auto-reader (490M)
Oct 2024
Decision
107d
Days
Class 2
Risk
About This 510(k) Submission
K241959 is an FDA 510(k) clearance for the 3M? Attest? Super Rapid Steam Clear Challenge Pack (1492PCD); 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 October 18, 2024, 107 days after receiving the submission on July 3, 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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