# K161045: Monoject

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Jun 17, 2016 after 65 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: 7 generations back to K801558 (1980). 19 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K142128: Kangaroo Enteral Feeding Syringes with Enfit Connector, Covidien (2015) Summary page 4.
- K152857: NeoMed NeoConnect Enteral Syringes with ENFit Connector and compatible NeoSecure Tip Caps, Neomed, Inc. (2015) Summary page 4.

## Most influential descendants
- K161963: Monoject Enteral Syringe with ENFit Connector (2016), 2 descendants of its own
- 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 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 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/K161045
Methodology: https://510kreport.com/methodology