# KPR: System, X-Ray, Stationary

- Device class: 2; regulation: 21 CFR 892.1680; FDA's rule: 510(k) required
- FDA decisions: 359
- 510(k) review time 2021–2025: median 103 days (middle half 34–156)
- Recalls: 95 (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)
- 2017: 6
- 2018: 15
- 2019: 12
- 2020: 16
- 2021: 6
- 2022: 8
- 2023: 9
- 2024: 11
- 2025: 8
- 2026: 6

## Most-cited predicates
- K012389: Revolution XR/D Digital Radiographic Imaging System (2001), cited by 9
- K042876: Urs LP Digital, Millennium, Radpro (2004), cited by 8
- K081722: YSIO (2008), cited by 7
- K102349: Aerodr System (2010), cited by 7
- K012546: Optima Urs Universal Radiographic System (2001), cited by 7
- K121513: Multix Fusion (2012), cited by 6
- K011486: Q-Rad Radiographic System (2001), cited by 5
- K062335: Sedecal X Plus LP Plus (2006), cited by 5
- K181629: GC85A (2018), cited by 5
- K090238: Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems (2009), cited by 5

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