# K120182: Neomed Gastrointestinal Tube and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Neomed, Inc.
- Decided: Apr 19, 2012 after 90 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- 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: 2 generations back to K820176 (1982). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060944: Nutrisafe 2, Vygon Corp. (2006) Summary page 1.
- K820441: Argyle PVC Feeding Tube, Sherwood Medical Co. (1982) Summary page 1.

## Indications for use
This product is intended for short-term use (<30 days) in neonatal and pediatric patients to provide nutrition via nasal or oral gastric placement.

Source page: https://510kreport.com/device/K120182
Methodology: https://510kreport.com/methodology