# K992494: Flexiflo Enteral Feeding Tube

- Pathway: 510(k) (Special)
- Applicant: Ross Product Div. Abbott Laboratories
- Decided: Aug 25, 1999 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K170162: Vesco Medical Nasoenteric Feeding Tubes (2017), 0 descendants of its own

## Indications for use
The Flexiflo/ROSS Enteral Feeding Tube is intended for nasoenteric placement into the stomach or 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. This device is also indicated for small bowel feeding of 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 tube may also be used for gastric decompression or evacuation of gastric contents.

Source page: https://510kreport.com/device/K992494
Methodology: https://510kreport.com/methodology