# K171857: AMSure® Enteral Feeding Syringe with ENFit Tip

- Pathway: 510(k) (Traditional)
- Applicant: Amsino International, Inc.
- Decided: Mar 30, 2018 after 282 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.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160419: Monoject Enteral Feeding Syringe with ENFit Connector, Covidien (2016) Summary page 4.

## Indications for use
The AMSure® Enteral Feeding Syringe with ENFit Tip 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 settings by users ranging from laypersons (under the supervision of a clinician) to clinicians in adults only.

Source page: https://510kreport.com/device/K171857
Methodology: https://510kreport.com/methodology