# K153688: Edi Catheter ENFit

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Critical Care AB
- Decided: Mar 2, 2017 after 435 days
- Product code: PIF (Gastrointestinal Tubes With Enteral Specific 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: 12 generations back to K902859 (1991). 63 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123149: Servo-I Ventilator System, Maquet Critical Care AB (2014) Summary page 5.

## Most influential descendants
- 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) (2026), 0 descendants of its own

## Recalls of this device
- Mar 20, 2019 · Class III · Z-1221-2019: Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes

## Indications for use
The Edi catheter ENFit is intended for: Administrating nutrition, fluids and medications via the naso-gastro-enteric route Aspiration via the naso-gastroenteric route Transfers electrical activity (Edi signals) to compatible SERVO ventilator systems on which NAVA and NAVA NIV are available

Source page: https://510kreport.com/device/K153688
Methodology: https://510kreport.com/methodology