# KXH: Cradle, Patient, Radiologic

- Device class: 1; regulation: 21 CFR 892.1830; FDA's rule: 510(k) exempt
- FDA decisions: 9
- 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)
- 1982: 1
- 1984: 1
- 1986: 1
- 1989: 1
- 1993: 2
- 1994: 1
- 1995: 1
- 2012: 1

## Most-cited predicates
- K930124: Variant of Octostop and Octopaque (1994), cited by 1

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