# QVB: Biological Sterilization Indicator With Indirect Growth Detection

- Device class: 2; regulation: 21 CFR 880.2806; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 2024: 1
- 2026: 2

## Most-cited predicates
- DEN220042: Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) (2024), cited by 2

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