QKM
5 FDA 510(k) clearances · Product code
122 daysmedian time to decision
295 days90th percentile
5clearances measured
FDA profile
- Official device name
- A Chemical Vapor Sterilization Multivariable Chemical Indicator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Medical specialty
- General Hospital
- FDA definition
- A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) (K232103) | Terragene S.A. | 2024-04-05 |
| 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K212022) | 3M Company | 2022-04-20 |
| CELERITY HP Chemical Indicator (K213262) | STERIS Corporation | 2022-01-07 |
| 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (K203284) | 3M Company | 2020-12-07 |
| 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K193110) | 3M Healthcare | 2020-03-13 |
Track QKM automatically
Every clearance here is in the API, with alerts when new ones post.