# K935781: Argyle Salem Sump Tube Anti-Reflux Valve Insertion Tray

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Jan 27, 1995 after 417 days
- Product code: FEG (Tube, Double Lumen For Intestinal Decompression And/Or Intubation)
- 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040388: Next Generation Salem Sump (2004), 5 descendants of its own
- K150711: Salem Sump Dual Lumen Stomach Tube with Multi-functional Port (2015), 3 descendants of its own
- 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

Source page: https://510kreport.com/device/K935781
Methodology: https://510kreport.com/methodology