# K152857: NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps

- Pathway: 510(k) (Traditional)
- Applicant: Neomed, Inc.
- Decided: Dec 17, 2015 after 78 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: 6 generations back to K801558 (1980). 18 ancestors in all.
30 later devices descend from it; 7 cite it directly.
1 of 49 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143344: NeoMed NeoConnect Enteral Syringes with ENFit Connector, Neomed, Inc. (2015) Summary page 4.
- K142128: Kangaroo Enteral Feeding Syringes with Enfit Connector, Covidien (2015) Summary page 4.

## Most influential descendants
- 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
- K161045: Monoject (2016), 3 descendants of its own

## Indications for use
NeoConnect™ Enteral Syringe with ENFit™ Connector: 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 enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups. NeoConnect™ NeoSecure™ Tip Cap: A NeoConnect™ Enteral Syringe with ENFit™ connector accessory used to prevent fluid loss and contamination of syringe contents until ready for use.

Source page: https://510kreport.com/device/K152857
Methodology: https://510kreport.com/methodology