# K193657: Disposable Enteral Feeding Syringe with Enfit Connector

- Pathway: 510(k) (Traditional)
- Applicant: Shinva Ande Healthcare Apparatus Co., Ltd.
- Decided: Sep 12, 2020 after 257 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.
1 later device descends from it; 1 cites 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)
- K161979: ENFit enteral syringe, Jiangyin Caina Technology Co., Ltd. (2017) Summary page 5.

## Most influential descendants
- K231300: Nutricair Enteral Syringe with ENFit (2023), 0 descendants of its own

## Indications for use
The Disposable Enteral Feeding Syringe with Enfit Connector 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 feeding 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/K193657
Methodology: https://510kreport.com/methodology