# K253715: Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critical Care AB
- Decided: Aug 26, 2026 after 275 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: 13 generations back to K902859 (1991). 64 ancestors in all.
No later device cites it as a predicate yet.
5 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153688: Edi Catheter ENFit, Maquet Critical Care AB (2017) Summary page 5.

## Indications for use
The Edi Catheter ENFit is intended for: administrating nutrition, fluids and medications via the naso-gastroenteric or oro-gastroenteric route aspiration via the naso-gastroenteric or oro-gastroenteric route transfer of electrical activity of the diaphragm (Edi signal) to compatible Servo ventilator systems on which neurally controlled ventilation modes are available.

Source page: https://510kreport.com/device/K253715
Methodology: https://510kreport.com/methodology