# K100288: Neomed Enteral Only Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Neomed, Inc.
- Decided: Aug 3, 2010 after 183 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
Longest line of descent: 3 generations back to K801558 (1980). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082654: Enteral Only Extension Set, Respironics, Inc. (2008) Summary page 1.

## Most influential descendants
- K120272: Ameritus Medical Enteral Feeding Extension Set (2012), 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

## Recalls of this device
- Oct 24, 2018 · Class III · Z-0526-2019: The sterile pouch label states the expiration date is 2016-11-19, but the correct expiration date is 2019-11-09. The case label and the shipper label have the correct date

## Indications for use
The NeoMed Enteral Only Extension Set is intended for use as an, extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental misconnection with an I.V. system to the enteral system or the enteral system to an I.V. system.

Source page: https://510kreport.com/device/K100288
Methodology: https://510kreport.com/methodology