# KPW: Device, Beam Limiting, X-Ray, Diagnostic

- Device class: 2; regulation: 21 CFR 892.1610; FDA's rule: 510(k) exempt
- FDA decisions: 16
- 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)
- 1978: 1
- 1979: 1
- 1981: 1
- 1982: 3
- 1990: 2
- 1991: 2
- 1995: 2
- 2003: 1
- 2006: 1
- 2010: 1

## Most-cited predicates
- K946320: R 302 (1995), cited by 2
- K030487: R 72 (2003), cited by 2
- K820306: Ralco Collimator, Automatic Radiographic (1982), cited by 1

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