510(k) · Cleared
ClearedAmt Button Replacement Gastrostomy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Technology, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Apr 16, 1998 as substantially equivalent to K843392 (American V. Mueller, 1984) after a 79-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.
- Decided
- Apr 16, 1998
- Review
- 79 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K843392 (1984). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK843392 Gauderer Gastrostomy ButtonAmerican V. Mueller · 1984
- This deviceK980305 Amt Button Replacement Gastrostomy DeviceApplied Medical Technology, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK170319 Low Profile Non-Balloon Feeding DeviceApplied Medical Technology, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K170319Low Profile Non-Balloon Feeding DeviceApplied Medical Technology, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843392 | Gauderer Gastrostomy Button | American V. Mueller | 1984 | — |
| 0 (this device) | K980305 | Amt Button Replacement Gastrostomy Device | Applied Medical Technology, Inc. | 1998 | — |
| +1 | K170319 | Low Profile Non-Balloon Feeding Device | Applied Medical Technology, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K843392 | Gauderer Gastrostomy ButtonSummary page 1…ame: Gastrointestinal Tube and Accessories (78KGC) Substantial Equivalency is claimed against the following devices: 1. Applied Medical Technology, Inc. - AMT Button - K843392 2. Microvasive/Boston Scientific Corp. - Button and Replacement Button 3. CR.Bard - Button and Replacement Button Device of Des… | 1984 |
| * | — | Button and Replacement Button Named without a submission number | |
| * | — | Button and Replacement Button Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170319 | Low Profile Non-Balloon Feeding Device | 2017 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K170319 (Applied Medical Technology, Inc., 2017) 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?
The AMT Button Replacement Gastrostomy Device is to be used as a replacement gastrostomy tube for a patient with a well established gastrostomy tract. This device will assist in providing nutrition directly into the stomach through an established stoma in a human patient who is unable to consume nutrition by conventional means. The AMT Button Replacement Gastrostomy Device can also deliver medication and allow for decompression of the stomach.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980305 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980305: Amt Button Replacement Gastrostomy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980305
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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