# K152246: Aquarius Stoma Measuring Device

- Pathway: 510(k) (Traditional)
- Applicant: Degania Silicone, Ltd.
- Decided: Jun 21, 2016 after 316 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: 1 generation back to K973893 (1997). 1 ancestor in all.
1 later device descends 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)
- K973893: Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring Device with Stop Valve, Amy Bae, Applied Medical Technologies (1997) Summary page 4.

## Most influential descendants
- K262038: danumed StomaMeter (2026), 0 descendants of its own

## Indications for use
The Aquarius™ Stoma Measuring Device is designed to determine the depth (length) of a well-established gastrostomy stoma tract in order to assist in proper length selection of the Aquarius™ Gastrostomy Button (G-Button). Intended for transient use (less than 60 minutes).

Source page: https://510kreport.com/device/K152246
Methodology: https://510kreport.com/methodology