# K161811: Medela Low Dose Enteral Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Medela, Inc.
- Decided: Feb 15, 2017 after 229 days
- Product code: PNR (Enteral Syringes With Enteral Specific Connectors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K801558 (1980). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161963: Monoject Enteral Syringe with ENFit Connector, Covidien (2016). Cleared while this submission was under review Summary page 4.

## Recalls of this device
- Dec 5, 2018 · Class III · Z-2061-2019: The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.

## Indications for use
The Medela Low Dose 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 enterally, into the gastrointestinal system of patients in all age groups. The enteral syringes are intended to be used in clinical settings by clinicians.

Source page: https://510kreport.com/device/K161811
Methodology: https://510kreport.com/methodology