# QBC: External Upper Limb Tremor Stimulator

- Device class: 2; regulation: 21 CFR 882.5897; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 119 days (middle half 114–168)
- 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)
- 2018: 2
- 2021: 1
- 2022: 1
- 2024: 1
- 2025: 2
- 2026: 2

## Most-cited predicates
- DEN170028: Cala ONE (2018), cited by 4
- K182706: External upper limb tremor stimulator (2018), cited by 3
- K203288: Cala Trio (2021), cited by 2
- K242259: Cala kIQ (2024), cited by 1
- K243848: Cala kIQ (2025), cited by 1
- K222237: Cala kIQ (2022), cited by 1

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