Submission Details
| 510(k) Number | K242538 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 26, 2024 |
| Decision Date | November 25, 2024 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
3M? Attest? Super Rapid Readout Biological Indicator 1493; 3M? Attest? Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M? Attest? Auto-reader 490; 3M? Attest? Auto-reader 490H; 3M? Attest? Mini Auto-reader 490M
Nov 2024
Decision
91d
Days
Class 2
Risk
About This 510(k) Submission
K242538 is an FDA 510(k) clearance for the 3M? Attest? Super Rapid Readout Biological Indicator 1493; 3M? Attest? Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 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 November 25, 2024, 91 days after receiving the submission on August 26, 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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