Data / Medical devices / A Chemical Vapor Sterilization Multivariable Chemical Indicator
A Chemical Vapor Sterilization Multivariable Chemical Indicator (QKM): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make A Chemical Vapor Sterilization Multivariable Chemical Indicator (product code QKM, Class 2, 21 CFR 880.2800). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on April 5, 2024, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- QKM
- Device class
- 2
- Regulation
- 880.2800
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| United Kingdom | 1 |
| Argentina | 1 |
Makers of A Chemical Vapor Sterilization Multivariable Chemical Indicator
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Albert Browne Ltd. | Leicester, United Kingdom | Complaint file establishment, Manufacturer | 1 | January 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 1 | April 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 1 | April 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | Brookings, SD, United States | Manufacturer | 1 | April 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Terragene SA | Alvear Santa Fe, Argentina | Manufacturer | 1 | April 5, 2024 | 0 | 0 | 0 | api.fda.gov |
| Steris Corporation | Mentor, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.