# K162340: Stomach Tube

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Co., Ltd.
- Decided: Oct 11, 2017 after 415 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: 7 generations back to K810156 (1981). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022112: Fortune All Silicone Stomach (Gastric) Tubes, Model 2020, Fortune Medical Instrument Corp. (2003) Summary page 4.
- K092628: Enteral Feeding Tube and Accessories, Feeding Tube Extension Set, Alan Reid (2010) Summary page 5.

## Indications for use
The Stomach Tube is intended for gastric decompression. It is used to drain undesirable contents from the stomach, or decompress the stomach. The device is available in sizes 6Fr to 22Fr for use in adults only.

Source page: https://510kreport.com/device/K162340
Methodology: https://510kreport.com/methodology