# MKQ: Processor, Cervical Cytology Slide, Automated

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 3
- Recalls: 17 (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)
- 2014: 7
- 2015: 2
- 2016: 6
- 2018: 3
- 2019: 1
- 2020: 1
- 2021: 4
- 2023: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- P950039: Thinprep (R) Processor, Model TP 2000 (1996), cited by 1

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