# K181787: Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Cedic S.R.L.
- Decided: Apr 25, 2019 after 294 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: 3 generations back to K913407 (1992). 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)
- K141753: Aquarius Nasal Feeding Tube, Degania Silicone, Ltd. (2014) Summary page 4.
- K831328: Neonatal Nasogastric Feeding Tube-, Corpak Medsystems (1983) Summary page 4.

## Indications for use
The Cediflo Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for patients 2 years and above which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract.Maximum duration of use: 42 days. The Cediflo Junior Enteral Feeding Tubes are intended for the administration of enteral nutrition, fluids, and/or medications by the nasoenteric route into the stomach or small intestine. Indicated for neonatal and pediatric patients which require nutritional support, are not able to meet their nutritional requirements by oral intake and have functioning and accessible gastrointestinal tract.

Source page: https://510kreport.com/device/K181787
Methodology: https://510kreport.com/methodology