# K151628: Medline ENFit Connectors

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Jul 24, 2015 after 37 days
- Product code: PIO (Enteral Specific Transition 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: 3 generations back to K940556 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140581: Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition Connector for Medication Port, Cedic S.R.L. (2014) Summary page 6.

## Recalls of this device
- Feb 13, 2026 · Class II · Z-1690-2026: Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and flu

## Indications for use
The Medline ENFit Transition Connector is intended for connecting an enteral feeding set with an ENFit connector to a gastronomy tube with funnel. The Medline ENFit G-Tube Connector is intended for connecting an enteral feeding set equipped with a stepped enteral distal end to a gastronomy tube equipped with an ENFit connector.

Source page: https://510kreport.com/device/K151628
Methodology: https://510kreport.com/methodology