CELERITY HP Chemical Indicator
FDA 510(k) K213262 · STERIS Corporation
510(k) numberK213262
Submission
- Device name
- CELERITY HP Chemical Indicator
- Applicant
- STERIS Corporation
Mentor, OH, US - Received
- September 30, 2021
- Decision date
- January 7, 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 |
| K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348EQKM · Traditional | 3M Company | 04/20/2022SE |
| 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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| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid…MED · Traditional | 04/08/2026SE |
| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | 09/24/2025SE |
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| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118JOJ · Special | 05/02/2025SE |
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Questions and answers
When was CELERITY HP Chemical Indicator cleared by the FDA?
CELERITY HP Chemical Indicator (K213262) received a 510(k) decision of Substantially Equivalent on January 7, 2022, 99 days after the submission was received.
What is the product code of K213262?
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.