510(k) K213262
K213262 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "CELERITY HP Chemical Indicator". The FDA issued a decision of Substantially Equivalent on January 7, 2022. The device falls under product code QKM (A Chemical Vapor Sterilization Multivariable Chemical Indicator), a Class II device regulated under 21 CFR 880.2800. STERIS Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2022
- Date Received
- September 30, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- A Chemical Vapor Sterilization Multivariable Chemical Indicator
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type
A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.