# K021991: Magnaflow Magnetically Guided Enteral Feeding Tube

- Pathway: 510(k) (Special)
- Applicant: Syncro Medical Innovations, Inc.
- Decided: Jul 18, 2002 after 30 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- 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: 1 generation back to K972437 (1998). 1 ancestor in all.
4 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)
- K972437: Ross Enteral Feeding Tube, Ross Products (1998) Summary page 1.

## Most influential descendants
- 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 MagndFlowB Magnetically Guided Enteral Feeding 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, bum 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.

Source page: https://510kreport.com/device/K021991
Methodology: https://510kreport.com/methodology