# HBI: Illuminator, Fiberoptic, Surgical Field

- Device class: 2; regulation: 21 CFR 878.4580; FDA's rule: 510(k) required
- FDA decisions: 28
- 510(k) review time 2021–2025: median 93 days (middle half 93–93)
- 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)
- 1992: 4
- 1993: 1
- 1998: 1
- 1999: 1
- 2002: 1
- 2005: 1
- 2011: 1
- 2015: 1
- 2016: 1
- 2023: 1

## Most-cited predicates
- K854587: Storz MVS Disposable Fiberoptic Lightpipe (1986), cited by 2
- K991208: Endoscopic Fiberoptic Cable (1999), cited by 2
- K052979: 1125 XSB Xenon Fiber-Optic Light Source (2005), cited by 1
- K111342: Light Guide Cable (2011), cited by 1

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