# K921104: Lopez Valve with NG Sump Tube

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Oct 26, 1992 after 231 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, 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/K921104
Methodology: https://510kreport.com/methodology