# K830710: Argyle Silicone Salem Sump Tube

- Pathway: 510(k) (Traditional)
- Applicant: Sherwood Medical Co.
- Decided: Mar 29, 1983 after 22 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Sep 18, 2025 · Class II · Z-0208-2026: 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.

Source page: https://510kreport.com/device/K830710
Methodology: https://510kreport.com/methodology