# K040388: Next Generation Salem Sump

- Pathway: 510(k) (Traditional)
- Applicant: Kendall
- Decided: May 17, 2004 after 90 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
Longest line of descent: 1 generation back to K915171 (1992). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935781: Argyle Salem Sump Tube Anti-Reflux Valve Insertion Tray, Sherwood Medical Co. (1995) Summary page 1.
- K960176: Davol Nasogastric Sump Tube W/Prevent Filter, C.R. Bard, Inc. (1996) Summary page 1.
- K915171: Lopez Valve TM  II, Icu Medical, Inc. (1992) Summary page 1.
- K921104: Lopez Valve with NG Sump Tube, Icu Medical, Inc. (1992) Summary page 1.

## Most influential descendants
- 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
- K053410: Gientriport with Universal Single Lumen Adaptor (2006), 0 descendants of its own

## Indications for use
The Next Generation Salem Sump is intended for gastric decompression and delivery of fluids, including irrigation, nutritional supplements, and medication, during the time period that gastric decompression is required.

Source page: https://510kreport.com/device/K040388
Methodology: https://510kreport.com/methodology