# K160642: Medline ENFit Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Nov 29, 2016 after 267 days
- Product code: PIF (Gastrointestinal Tubes 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.
1 later device descends from it; 1 cites it directly.
0 of 21 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
- K202285: Medline ENfit OTC Feeding Syringe (2020), 0 descendants of its own

## Indications for use
The Medline ENFit Syringe is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) to measure and administer enteral nutrition.

Source page: https://510kreport.com/device/K160642
Methodology: https://510kreport.com/methodology