# K191844: Fidmi Low Profile Enteral Feeding Device

- Pathway: 510(k) (Traditional)
- Applicant: Fidmi Medical, Ltd.
- Decided: Sep 30, 2019 after 83 days
- Product code: KGC (Tube, Gastro-Enterostomy)
- 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: 2 generations back to K910584 (1991). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161003: EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector, Boston Scientific Corporation (2016) Summary page 4.

## Indications for use
The Fidmi Low Profile Enteral Feeding Device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means. Fidmi Low Profile Enteral Feeding Device Measuring kit is indicated for measuring the length of the stoma prior to placement of a low-profile feeding tube. The Fidmi Low Profile Enteral Feeding Device Replaceable Tube is intended for use only with the Fidmi Low Profile Enteral Feeding Device, for the replacement of an existing tube. It is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.

Source page: https://510kreport.com/device/K191844
Methodology: https://510kreport.com/methodology