Submission Details
| 510(k) Number | K241710 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 14, 2024 |
| Decision Date | September 12, 2024 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
3M? Attest? Super Rapid Readout Biological Indicator 1492V; 3M? Attest? Auto-reader 490; 3M? Attest? Auto-reader 490H; 3M? Attest? Mini Auto-reader 490M
Sep 2024
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K241710 is an FDA 510(k) clearance for the 3M? Attest? Super Rapid Readout Biological Indicator 1492V; 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 September 12, 2024, 90 days after receiving the submission on June 14, 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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