# LYK: Angioscope

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 41
- 510(k) review time 2021–2025: median 113 days (middle half 113–113)
- 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)
- 1994: 2
- 1995: 3
- 1997: 1
- 2000: 1
- 2001: 1
- 2002: 1
- 2005: 1
- 2006: 1
- 2025: 1
- 2026: 1

## Most-cited predicates
- K911278: Olympus AF Angioscope System (1991), cited by 4
- K952638: 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as the Modified Angioscope[ (1995), cited by 3
- K860858: Olympus PF-18 & PF-25 Ultrathin Angioscope (1986), cited by 2
- K050808: Coronary Sinus Access Kit, Model KCS8F-01 (2005), cited by 1
- K883000: Acs Angioscope Guide Wire (1988), cited by 1
- K923996: Disposable Vascular Angioscope (1993), cited by 1
- K894459: Angioscope (1990), cited by 1
- K902329: Ultra-VU Angioscope (1990), cited by 1

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