# K260110: danumed Extension Set for Gastrostomy Button

- Pathway: 510(k) (Traditional)
- Applicant: Danumed Medizintechnik GmbH
- Decided: Sep 10, 2026 after 239 days
- Product code: PIF (Gastrointestinal Tubes With Enteral Specific Connectors)
- 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 K132686 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141631: Aquarius Extension Feeding Set, Degania Silicone, Ltd. (2014) Summary page 5.

## Indications for use
This enteral extension set may only be used for enteral feeding and/or to administer medications via the stomach. It may only be used on patients who have a low profile gastrostomy button (button) inserted. It serves to connect the button and feeding set or enteral syringes. The enteral extension set may only be used on one patient (single-patient product) and must be replaced after 14 days.

Source page: https://510kreport.com/device/K260110
Methodology: https://510kreport.com/methodology