# K150711: Salem Sump Dual Lumen Stomach Tube with Multi-functional Port

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Oct 8, 2015 after 203 days
- Product code: PIF (Gastrointestinal Tubes With Enteral Specific Connectors)
- 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: 2 generations back to K915171 (1992). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040388: Next Generation Salem Sump, Kendall (2004) Summary page 4.

## Most influential descendants
- K190923: Salem Sump Dual Lumen Stomach Tube with ENFit Connection (2019), 2 descendants of its own
- K222846: AMT G-Tube Balloon Gastrostomy Feeding Device (2023), 0 descendants of its own
- K213174: Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (2022), 0 descendants of its own

## Indications for use
Intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication during the time period that gastric decompression is required. The device is intended for patients with age of two-year and older.

Source page: https://510kreport.com/device/K150711
Methodology: https://510kreport.com/methodology