Submission Details
| 510(k) Number | K212022 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 29, 2021 |
| Decision Date | April 20, 2022 |
| Days to Decision | 295 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
Apr 2022
Decision
295d
Days
Class 2
Risk
About This 510(k) Submission
K212022 is an FDA 510(k) clearance for the 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E, a A Chemical Vapor Sterilization Multivariable Chemical Indicator (Class II — Special Controls, product code QKM), submitted by 3M Company (St. Pauk, US). The FDA issued a Cleared decision on April 20, 2022, 295 days after receiving the submission on June 29, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.
Device Classification
| Product Code | QKM — A Chemical Vapor Sterilization Multivariable Chemical Indicator |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.2800 |
| Definition | A Chemical Vapor Sterilization Multivariable Chemical Indicator Monitors Two Or More Parameters Of A Chemical Vapor Sterilization Process. |
Manufacturer
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