# K190923: Salem Sump Dual Lumen Stomach Tube with ENFit Connection

- Pathway: 510(k) (Traditional)
- Applicant: Cardinalhealth
- Decided: Nov 7, 2019 after 212 days
- Product code: PIF (Gastrointestinal Tubes With Enteral Specific Connectors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915171 (1992). 6 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K150711: Salem Sump Dual Lumen Stomach Tube with Multi-functional Port, Covidien (2015) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Sep 18, 2025 · Class II · Z-0206-2026: Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

## Indications for use
The Salem Sump™ 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/K190923
Methodology: https://510kreport.com/methodology