# K810156: Argyle Salem Sump Tube

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Mar 2, 1981 after 40 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 2 cite it directly.
0 of 12 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
- K971354: Knott NG Tube (1997), 8 descendants of its own
- K020005: Infant Feeding Tubes (2002), 7 descendants of its own
- K052903: Pediatric Feeding Tube (2005), 6 descendants of its own
- K072756: Non-IV Adapter for Infant NG Tube (2007), 5 descendants of its own
- K082710: Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set (2009), 4 descendants of its own

## Recalls of this device
- Sep 18, 2025 · Class II · Z-0207-2026: 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.
- Jul 24, 2024 · Class II · Z-3301-2024: The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
- Oct 31, 2018 · Class II · Z-0597-2019: This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube

Source page: https://510kreport.com/device/K810156
Methodology: https://510kreport.com/methodology