# NQE: Microscope, Specular

- Device class: 2; regulation: 21 CFR 886.1850; FDA's rule: 510(k) required
- FDA decisions: 9
- Recalls: 1 (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)
- 2004: 1
- 2008: 1
- 2012: 1
- 2013: 1
- 2015: 1
- 2016: 1
- 2018: 2
- 2020: 1

## Most-cited predicates
- K120264: Konan Specular Microscope Xiv (2012), cited by 6
- K062763: Noncon Robo Pachy F&a (2008), cited by 2
- K142417: SP-1PSpecular Microscope (2015), cited by 1
- K130565: Specular Microscope Cem-530 (2013), cited by 1
- K151706: Specular Microscope CEM- 530 (2016), cited by 1

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