# PIO: Enteral Specific Transition Connectors

- Device class: 2; regulation: 21 CFR 876.5980; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 263 days (middle half 188–269)
- 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)
- 2014: 1
- 2015: 3
- 2016: 1
- 2017: 1
- 2022: 1
- 2024: 2

## Most-cited predicates
- K140581: Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port (2014), cited by 7
- K150034: AMT Enteral Transition Adapters (2015), cited by 1

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