# K222846: AMT G-Tube Balloon Gastrostomy Feeding Device

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Dec 18, 2023 after 453 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: 4 generations back to K922667 (1993). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161413: Low Profile Balloon Feeding Device, Applied Medical Technology, Inc. (2017) Summary page 5.
- K190923: Salem Sump Dual Lumen Stomach Tube with ENFit Connection, Cardinalhealth (2019) Summary page 5.
- K971434: A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding Device, Applied Medical Technologies (1998) Summary page 5.

## Indications for use
The AMT G-Tube Balloon Gastrostomy Feeding Device is indicated to be used as a percutaneous gastrostomy tube. This device will assist in providing nutrition directly into the stomach through a secured (initial placement) or formed (replacement) stoma in a human patient, 10kg or above, who is unable to consume nutrition by conventional means. The AMT G-Tube Balloon Gastrostomy Feeding Device can also deliver medication and allow for decompression of the stomach.

Source page: https://510kreport.com/device/K222846
Methodology: https://510kreport.com/methodology