510(k) · Cleared
ClearedAmt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring Device with Stop Valve, Amy Bae
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Technologies · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Dec 19, 1997 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Dec 19, 1997
- Review
- 66 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK973893 Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device…Applied Medical Technologies · 1997
- Descendant · cites it directly · 1 of its ownK152246 Aquarius Stoma Measuring DeviceDegania Silicone, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK262038 danumed StomaMeterDanumed Medizintechnik GmbH · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973893 | Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon… | Applied Medical Technologies | 1997 | — |
| +1 | K152246 | Aquarius Stoma Measuring Device | Degania Silicone, Ltd. | 2016 | — |
| +2 | K262038 | danumed StomaMeter | Danumed Medizintechnik GmbH | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152246 | Aquarius Stoma Measuring Device | 2016 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K152246 (Degania Silicone, Ltd., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973893 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973893: Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring Device with Stop Valve, Amy Bae.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973893
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026