# OYC: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 2
- Recalls: 5 (1 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: 1
- 2015: 1
- 2016: 17
- 2017: 13
- 2018: 9
- 2019: 2

## Most-cited predicates

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