# K971434: A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding Device

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technologies
- Decided: Aug 17, 1998 after 486 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K222846: AMT G-Tube Balloon Gastrostomy Feeding Device (2023), 0 descendants of its own
- K142297: Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set (2015), 0 descendants of its own

## Indications for use
To provide nutrition directly into the stomach through an established stoma in a patient who is unable to consume nutrition by conventional means.

Source page: https://510kreport.com/device/K971434
Methodology: https://510kreport.com/methodology