# K972437: Ross Enteral Feeding Tube

- Pathway: 510(k) (Traditional)
- Applicant: Ross Products
- Decided: Jan 26, 1998 after 210 days
- Product code: FPD (Tube, Feeding)
- 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K021991: Magnaflow Magnetically Guided Enteral Feeding Tube (2002), 4 descendants of its own
- K072787: Gabriel Blue Tube Magnetically Guided Enteral Feeding Tube, Model GFT-111 (2007), 3 descendants of its own
- K110005: Syncro - Blue Tube, the Magnetically Guided Enteral Feeding Tube- 8FR Tube (2011), 2 descendants of its own
- K160787: Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet (2016), 1 descendant of its own
- K191784: Gabriel Feeding Tube with Balloon, and EnFit Connector (2019), 0 descendants of its own

## Indications for use
The Flexiflo Magnetically Guided Enteral Feeding Tube system is intended for direct placement in the small bowel. The tube functions as a conduit to facilitate enteral feeding, and may be used in pediatric, adult or elderly patients who cannot consume an adequate diet orally. Small bowel feeding may be indicated for patients with a functioning gut who require short- to moderate-term feeding support, such as post-trauma patients, post-surgical patients, burn patients, general trauma patients, high-risk patients prone to tube misplacement complications, and patients in whom malnutrition exists, or may result, secondary to an underlying disease or condition. The external steering magnet functions as a guidance tool to assist in the safe, rapid placement of the feeding tube into the small bowel. The pH tape is used to measure the acidity or alkalinity of gastric and small bowel fluids that are obtained during initial placement.

Source page: https://510kreport.com/device/K972437
Methodology: https://510kreport.com/methodology