# K211025: Oral/Enteral Syringe with ENFit connector

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Tianyi Medical Appliance Co., Ltd.
- Decided: Jun 30, 2021 after 85 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.
2 later devices descend from it; 2 cite it directly.
0 of 23 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 5.

## Most influential descendants
- K251585: Profoject™ Enteral Feeding Syringe (2025), 0 descendants of its own
- K222772: Oral/Enteral Syringe with ENFit connector (2023), 0 descendants of its own

## Indications for use
The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.

Source page: https://510kreport.com/device/K211025
Methodology: https://510kreport.com/methodology