A Chemical Vapor Sterilization Multivariable Chemical Indicator
The Chemical Vapor Sterilization Multivariable Chemical Indicator is a Class 2 general hospital device that monitors two or more parameters of a chemical vapor sterilization process simultaneously, providing verification that the sterilization conditions have been met. It requires 510(k) clearance and is regulated under 21 CFR 880.2800 within the General Hospital medical specialty. The product code is QKM. The device is not an implant and is not flagged as life-sustaining.
Basic Information
- Product Code
- QKM
- Device Class
- FDA class 2
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | Apr 05, 2024 | Substantially Equivalent | Terragene S.A. |
| K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | Apr 20, 2022 | Substantially Equivalent | 3M Company |
| K213262 | CELERITY HP Chemical Indicator | Jan 07, 2022 | Substantially Equivalent | STERIS Corporation |
| K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | Dec 07, 2020 | Substantially Equivalent | 3M Company |
| K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | Mar 13, 2020 | Substantially Equivalent | 3M Healthcare |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.