3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
FDA 510(k) K212022 · 3M Company
510(k) numberK212022
Submission
- Device name
- 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E
- Applicant
- 3M Company
St. Paul, MN, US - Received
- June 29, 2021
- Decision date
- April 20, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QKM – A Chemical Vapor Sterilization Multivariable Chemical Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.
Other 510(k)s with product code QKM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye®…QKM · Traditional | Terragene S.A. | 04/05/2024SE |
| K213262 | CELERITY HP Chemical IndicatorQKM · Traditional | STERIS Corporation | 01/07/2022SE |
| K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical IndicatorQKM · Special | 3M Company | 12/07/2020SE |
| K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EQKM · Traditional | 3M Healthcare | 03/13/2020SE |
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Questions and answers
When was 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E cleared by the FDA?
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K212022) received a 510(k) decision of Substantially Equivalent on April 20, 2022, 295 days after the submission was received.
What is the product code of K212022?
The FDA product code is QKM – A Chemical Vapor Sterilization Multivariable Chemical Indicator, a Class II (moderate risk) device regulated under 21 CFR 880.2800.