# K143378: AQUARIUS Gastrostomy Replacement Tube

- Pathway: 510(k) (Special)
- Applicant: Degania Silicone, Ltd.
- Decided: Dec 29, 2014 after 34 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: 1 generation back to K070124 (2007). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070124: Gastrostomy Replacement Tube, Model 253, Degania Silicone, Ltd. (2007) Summary page 4.

## Most influential descendants
- K180622: Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port (2018), 0 descendants of its own

## Indications for use
AQUARIUS™ Gastrostomy Replacement Tube is intended for use in a well-established gastrostomy tract for feeding and/or administration of medications. May be used for gastric decompression.

Source page: https://510kreport.com/device/K143378
Methodology: https://510kreport.com/methodology