# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Neomed, Inc.
- Decided: Jun 17, 2016 after 65 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: 7 generations back to K801558 (1980). 19 ancestors in all.
21 later devices descend from it; 10 cite it directly.
1 of 41 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152857: NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps, Neomed, Inc. (2015) Summary page 4.

## Most influential descendants
- 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
- K161979: ENFit enteral syringe (2017), 3 descendants of its own
- K211025: Oral/Enteral Syringe with ENFit connector (2021), 2 descendants of its own
- K210971: EnteraLoc Flow (2021), 1 descendant of its own
- K193657: Disposable Enteral Feeding Syringe with Enfit Connector (2020), 1 descendant 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 orally or 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.

Source page: https://510kreport.com/device/K161039
Methodology: https://510kreport.com/methodology