# K202285: Medline ENfit OTC Feeding Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Oct 9, 2020 after 58 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)
- K160642: Medline ENFit Syringe, Medline Industries, Inc. (2016) Summary page 5.

## Indications for use
The Medline ENFit OTC Feeding Syringe is intended for Over-The-Counter use to measure and administer enteral nutrition.

Source page: https://510kreport.com/device/K202285
Methodology: https://510kreport.com/methodology