# K973893: Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring Device with Stop Valve, Amy Bae

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technologies
- Decided: Dec 19, 1997 after 66 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; 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K152246: Aquarius Stoma Measuring Device (2016), 1 descendant of its own
- K262038: danumed StomaMeter (2026), 0 descendants of its own

## Indications for use
The AMT Balloon Stoma Measuring Devices are to be used by medical professionals and home health givers in association with replacement gastrostomy feeding devices. The purpose of the AMT Balloon Stoma Measuring Devices is to aid in determining the depth (length) of an established stoma tract in order to assist in determining the proper length replacement gastrostomy feeding device to be used.

Source page: https://510kreport.com/device/K973893
Methodology: https://510kreport.com/methodology