# QKM: A Chemical Vapor Sterilization Multivariable Chemical Indicator

- Device class: 2; regulation: 21 CFR 880.2800; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 266 days (middle half 183–281)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2020: 2
- 2022: 2
- 2024: 1

## Most-cited predicates
- K203284: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (2020), cited by 2
- K213262: CELERITY HP Chemical Indicator (2022), cited by 1
- K193110: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (2020), cited by 1
- K212022: 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (2022), cited by 1

Source page: https://510kreport.com/product-code/QKM
Data by year (CSV): https://510kreport.com/product-code/QKM.csv