# K161979: ENFit enteral syringe

- Pathway: 510(k) (Traditional)
- Applicant: Jiangyin Caina Technology Co., Ltd.
- Decided: Mar 22, 2017 after 247 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.
3 later devices descend from it; 2 cite it directly.
0 of 24 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
- K193657: Disposable Enteral Feeding Syringe with Enfit Connector (2020), 1 descendant of its own
- K231300: Nutricair Enteral Syringe with ENFit (2023), 0 descendants of its own
- K203410: ENFit Disposable Enteral Syringe (2021), 0 descendants of its own

## Indications for use
The proposed device 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/K161979
Methodology: https://510kreport.com/methodology