# K962850: Tum-E-Vac

- Pathway: 510(k) (Traditional)
- Applicant: Ethox Corp.
- Decided: Feb 21, 1997 after 214 days
- Product code: KDH (Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration)
- 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.
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. The FDA summary names no predicate by number.

## Indications for use
Disposable, non-sterile tube for gastric lavage.

Source page: https://510kreport.com/device/K962850
Methodology: https://510kreport.com/methodology