3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
FDA 510(k) K203284 · 3M Company
510(k) numberK203284
Submission
- Device name
- 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator
- Applicant
- 3M Company
St. Paul, MN, US - Received
- November 9, 2020
- Decision date
- December 7, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EQKM · Traditional | 3M Company | 04/20/2022SE |
| K213262 | CELERITY HP Chemical IndicatorQKM · Traditional | STERIS Corporation | 01/07/2022SE |
| K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EQKM · Traditional | 3M Healthcare | 03/13/2020SE |
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| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 10/18/2024SE |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional | 09/12/2024SE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator cleared by the FDA?
3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (K203284) received a 510(k) decision of Substantially Equivalent on December 7, 2020, 28 days after the submission was received.
What is the product code of K203284?
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.