QKM · A Chemical Vapor Sterilization Multivariable Chemical Indicator
General Hospital · 21 CFR 880.2800 · Class 2
Overview
| Product Code | QKM |
|---|---|
| Device Name | A Chemical Vapor Sterilization Multivariable Chemical Indicator |
| Regulation | 21 CFR 880.2800 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | Terragene S.A. | Apr 5, 2024 | SESE |
| K212022 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Company | Apr 20, 2022 | SESE |
| K213262 | CELERITY HP Chemical Indicator | STERIS Corporation | Jan 7, 2022 | SESE |
| K203284 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator | 3M Company | Dec 7, 2020 | SESE |
| K193110 | 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E | 3M Healthcare | Mar 13, 2020 | SESE |
Top Applicants
- 3M Company — 2 clearances
- 3M Healthcare — 1 clearance
- STERIS Corporation — 1 clearance
- Terragene S.A. — 1 clearance
