# K143344: NeoMed NeoConnect Enteral Syringes with ENFit Connector

- Pathway: 510(k) (Traditional)
- Applicant: Neomed, Inc.
- Decided: Apr 9, 2015 after 139 days
- Product code: PNR (Enteral Syringes With Enteral Specific Connectors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K951871 (1995). 3 ancestors in all.
34 later devices descend from it; 2 cite it directly.
1 of 38 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122373: Neomed Oral/Enteral Syringe, Neomed, Inc. (2012) Summary page 4.

## Most influential descendants
- K152857: NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps (2015), 30 descendants of its own
- 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), 21 descendants of its own
- 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), 5 descendants of its own
- K160419: Monoject Enteral Feeding Syringe with ENFit Connector (2016), 4 descendants of its own
- K161979: ENFit enteral syringe (2017), 3 descendants of its own

## Indications for use
The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body via extension sets and feeding tubes in neonatal and small pediatric patients.

Source page: https://510kreport.com/device/K143344
Methodology: https://510kreport.com/methodology