# K161963: Monoject Enteral Syringe with ENFit Connector

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Sep 1, 2016 after 45 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). 21 ancestors in all.
2 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)
- K160419: Monoject Enteral Feeding Syringe with ENFit Connector, Covidien (2016) Summary page 4.
- K161045: Monoject, Covidien (2016) Summary page 4.

## Most influential descendants
- K170371: DASH 3 ENFit Syringe, DASH 3 Eccentric ENFit Syringe, DASH 3 Plus ENFit Syringe, DASH 3 Plus Eccentric ENFit Syringe, DASH 3 ENFit Low Dose Tip Syringe (2017), 0 descendants of its own
- K161811: Medela Low Dose Enteral Syringe (2017), 0 descendants of its own

## Indications for use
The Monoject™ Enteral 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, either orally or enterally, into the gastrointestinal system of a patient. The oral/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 all age groups.

Source page: https://510kreport.com/device/K161963
Methodology: https://510kreport.com/methodology