# K082238: Neomed Polyurethane Feeding Tube

- Pathway: 510(k) (Special)
- Applicant: Neomed, Inc.
- Decided: Oct 1, 2008 after 55 days
- Product code: FPD (Tube, Feeding)
- 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
Longest line of descent: 2 generations back to K945012 (1995). 2 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K072881: NEOMED Enteral FEEDING TUBE, Neomed, Inc. (2008) Summary page 1.

## Most influential descendants
- K100526: Ameritus Entral (TM) Enteral Feeding Tube (2010), 2 descendants of its own
- K180236: VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (2019), 1 descendant of its own
- K200082: BD Univia RightFit Enteral Extension Sets and Transitional Adapters (2020), 0 descendants of its own
- K100366: Medicina Enteral Feeding Tubes and Accessories Model MGX/YY (2010), 0 descendants of its own

## Recalls of this device
- Jun 4, 2018 · Class II · Z-0093-2019: Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure.

## Indications for use
The NeoMed Polyurethane Feeding Tube is intended for nasogastric or orogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.

Source page: https://510kreport.com/device/K082238
Methodology: https://510kreport.com/methodology