510(k) · Cleared
ClearedA.M.T. G-Tube Balloon Replacement Gastrostomy Feeding Device
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 Aug 17, 1998 after a 486-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Aug 17, 1998
- Review
- 486 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK971434 A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding DeviceApplied Medical Technologies · 1998
- Descendant · cites it directly · 0 of its ownK222846 AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK142297 Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension…Xeridiem (Formerly Mri) · 2015 · Recalled
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) | K971434 | A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding Device | Applied Medical Technologies | 1998 | — |
| +1 | K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. | 2023 | — |
| +1 | K142297 | Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo… | Xeridiem (Formerly Mri) | 2015 | 104 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2023 | 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)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K222846 (Applied Medical Technology, Inc., 2023) has gone furthest, with 0 descendants 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?
To provide nutrition directly into the stomach through an established stoma in a patient who is unable to consume nutrition by conventional means.
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/K971434 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971434: A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971434
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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