# IWE: Monitor, Patient Position, Light-Beam

- Device class: 1; regulation: 21 CFR 892.5780; FDA's rule: 510(k) exempt
- FDA decisions: 28
- Recalls: 6 (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)
- 1989: 1
- 1990: 1
- 1991: 1
- 1992: 1
- 1993: 5
- 1994: 4
- 1995: 4
- 1996: 1
- 1997: 1
- 2015: 1

## Most-cited predicates
- K872489: Centralite (1987), cited by 1
- K943381: Laser Alignment Tool (1994), cited by 1
- K930295: Patpos Compact (1993), cited by 1

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