# K213174: Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: May 19, 2022 after 233 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: 4 generations back to K915171 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190923: Salem Sump Dual Lumen Stomach Tube with ENFit Connection, Cardinalhealth (2019) Summary page 4.

## Indications for use
The Salem Sump™ Silicone Dual Lumen Stomach Tube with ENFit™ Connection is intended for gastric decompression and administration of nutrition, fluids, and medication. The device is intended for patients with age of two and older.

Source page: https://510kreport.com/device/K213174
Methodology: https://510kreport.com/methodology