# K170319: Low Profile Non-Balloon Feeding Device

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Oct 6, 2017 after 247 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: 2 generations back to K843392 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980305: Amt Button Replacement Gastrostomy Device, Applied Medical Technology, Inc. (1998) Summary page 4.
- K043027: Monarch, Transshaping Gastrostomy Tube, Model 9-XX20, Applied Medical Technology, Inc. (2004) Summary page 4.

## Indications for use
The Low Profile Non-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.

Source page: https://510kreport.com/device/K170319
Methodology: https://510kreport.com/methodology