# K203410: ENFit Disposable Enteral Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Shantou Wealy Medical Instrument Co.,Ltd
- Decided: Jun 28, 2021 after 221 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: 9 generations back to K801558 (1980). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161979: ENFit enteral syringe, Jiangyin Caina Technology Co., Ltd. (2017) Summary page 4.

## Indications for use
Wealy ENFit® Disposable Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.

Source page: https://510kreport.com/device/K203410
Methodology: https://510kreport.com/methodology