# K161413: Low Profile Balloon Feeding Device

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Feb 9, 2017 after 262 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: 3 generations back to K922667 (1993). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122653: Mic-Key SF Low Profile Gastrostomy Tube and Accessories, Kimberly-Clark Corporation (2013) Summary page 4.

## Most influential descendants
- K222846: AMT G-Tube Balloon Gastrostomy Feeding Device (2023), 0 descendants of its own

## Indications for use
The Low Profile Balloon Feeding Device is indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma. The Low Profile Balloon Feeding Device is intended for all age groups.

Source page: https://510kreport.com/device/K161413
Methodology: https://510kreport.com/methodology