Product code
QKM: A chemical vapor sterilization multivariable chemical indicator
FDA product code · Class II · General Hospital
Key facts
| Product code | QKM |
|---|---|
| Device | A chemical vapor sterilization multivariable chemical indicator |
| Device class | Class II |
| Regulation number | 880.2800 |
| Review panel | General Hospital |
| Medical specialty | General Hospital |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database