# PNR: Enteral Syringes With Enteral Specific Connectors

- Device class: 2; regulation: 21 CFR 876.5980; FDA's rule: 510(k) required
- FDA decisions: 35
- 510(k) review time 2021–2025: median 129 days (middle half 58–241)
- Recalls: 4 (4 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: 3
- 2019: 2
- 2020: 3
- 2021: 5
- 2022: 2
- 2023: 2
- 2024: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- K161039: NeoConnect Oral/Enteral Syringes with ENFit connector (12 mL to 100 mL) and NeoConnect Low Dose Tip Oral/Enteral Syringes with ENFit connector (0.5 mL to 6mL) (2016), cited by 10
- K152857: NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps (2015), cited by 7
- K142128: Kangaroo Enteral Feeding Syringes with Enfit Connector (2015), cited by 4
- K183540: Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) (2019), cited by 4
- K161979: ENFit enteral syringe (2017), cited by 2
- K211025: Oral/Enteral Syringe with ENFit connector (2021), cited by 2
- K161963: Monoject Enteral Syringe with ENFit Connector (2016), cited by 2
- K160419: Monoject Enteral Feeding Syringe with ENFit Connector (2016), cited by 2
- K143344: NeoMed NeoConnect Enteral Syringes with ENFit Connector (2015), cited by 2
- K161045: Monoject (2016), cited by 2

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