K213262 is an FDA 510(k) clearance for the CELERITY HP Chemical Indicator. This device is classified as a A Chemical Vapor Sterilization Multivariable Chemical Indicator (Class II - Special Controls, product code QKM).
Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on January 7, 2022, 99 days after receiving the submission on September 30, 2021.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2800. A Chemical Vapor Sterilization Multivariable Chemical Indicator Monitors Two Or More Parameters Of A Chemical Vapor Sterilization Process..
| 510(k) Number | K213262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2021 |
| Decision Date | January 07, 2022 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| 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. |