# K162254: Cedic Enteral ENFit Transition Connectors

- Pathway: 510(k) (Traditional)
- Applicant: Cedic S.R.L.
- Decided: May 4, 2017 after 267 days
- Product code: PIO (Enteral Specific Transition 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: 4 generations back to K940556 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150034: AMT Enteral Transition Adapters, Applied Medical Technology, Inc. (2015) Summary page 6.

## Indications for use
The Cedic F 00126 ENFit to Reverse Luer Transition Connector is intended to connect an enteral female ENFit giving set to the “g” port of the AbbVie PEG-J enteral male Luer catheter. The Cedic F 00128 Luer to ENFit Transition Connector is intended to connect the AbbVie Duopa Medication Cassette Reservoir delivery system to an enteral male ENFit catheter.

Source page: https://510kreport.com/device/K162254
Methodology: https://510kreport.com/methodology