# PIF: Gastrointestinal Tubes With Enteral Specific Connectors

- Device class: 2; regulation: 21 CFR 876.5980; FDA's rule: 510(k) required
- FDA decisions: 52
- 510(k) review time 2021–2025: median 224 days (middle half 130–251)
- Recalls: 107 (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)
- 2017: 5
- 2018: 2
- 2019: 7
- 2020: 4
- 2021: 4
- 2022: 4
- 2023: 4
- 2024: 2
- 2025: 2
- 2026: 3

## Most-cited predicates
- K150084: Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector (2015), cited by 3
- K150286: Medline Enteral Feeding Sets (2015), cited by 3
- K190310: U Deliver Bolink ENFit Enteral Feeding Sets (2019), cited by 2
- K142539: EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set (2015), cited by 2
- K190923: Salem Sump Dual Lumen Stomach Tube with ENFit Connection (2019), cited by 2
- K142012: Farrell Valve System with Equilibrium Technology and Enfit Enteral Connectors (2014), cited by 1
- K210971: EnteraLoc Flow (2021), cited by 1
- K181276: CONOD Enteral Feeding Sets (2018), cited by 1
- K213258: Nasogastric Feeding Tubes - ENFit Port - PVC (2022), cited by 1
- K170555: U Deliver Bolink ENFit Enteral Feeding Sets (2017), cited by 1

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