# QKZ: Magnetically Maneuvered Capsule Endoscopy System

- Device class: 2; regulation: 21 CFR 876.1310; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 92 days (middle half 31–172)
- 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: 1
- 2021: 1
- 2022: 1
- 2023: 2
- 2024: 1

## Most-cited predicates
- DEN190037: NaviCam Capsule Endoscope System with NaviCam Stomach Capsule (2020), cited by 2
- K203192: NaviCam Xpress Stomach System (2021), cited by 2
- K231960: NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether (2023), cited by 1
- K221608: NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether (2022), cited by 1

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