# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Neomed, Inc.
- Decided: Apr 30, 2019 after 131 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: 8 generations back to K801558 (1980). 20 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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), Neomed, Inc. (2016) Summary page 4.

## Most influential descendants
- K210971: EnteraLoc Flow (2021), 1 descendant of its own
- K253268: Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap (2026), 0 descendants of its own
- K223683: EnteraLoc Flow (2023), 0 descendants of its own
- K222155: O-ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) (2022), 0 descendants of its own
- K203613: ENFit Reusable Enteral Syringe (2021), 0 descendants of its own

## Indications for use
Single Use Oral/Enteral Syringes with ENFit Connector (provided sterile and non-sterile): 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 and non-clinical settings by users ranging from clinicians to laypersons in all age groups. Reusable Oral/Enteral Syringes with ENFit Connector (provided non-sterile): 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 multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.

Source page: https://510kreport.com/device/K183540
Methodology: https://510kreport.com/methodology