# K182804: Traditional Length GJ Feeding Device

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Mar 1, 2019 after 150 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 K123716 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123716: Amt Low-Profile Transgastric-Jejunal Feeding Tube Kit, Applied Medical Technology, Inc. (2013) Summary page 4.

## Indications for use
The Traditional Length GJ Feeding Device is indicated for use in adult, adolescent, children, and infant patients over 10kg who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy. The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.

Source page: https://510kreport.com/device/K182804
Methodology: https://510kreport.com/methodology