510(k) · Cleared
ClearedAMT G-Tube Balloon Gastrostomy Feeding 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 Dec 18, 2023 as substantially equivalent to K161413 (Applied Medical Technology, Inc., 2017) and 2 other predicates after a 453-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Dec 18, 2023
- Review
- 453 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K922667 (1993). 13 ancestors in all, the oldest K915171 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK922667 Mic Low Profile Gastrostomy TubeMedical Innovations Corp. · 1993 · Recalled
- 3 generations backK993138 Ballard Mic-Key G Low Profile Gastrostomy Replacement KitBallard Medical Products · 1999
- 2 generations backK122653 Mic-Key SF Low Profile Gastrostomy Tube and AccessoriesKimberly-Clark Corporation · 2013 · Recalled
- 1 generation backK161413 Low Profile Balloon Feeding DeviceApplied Medical Technology, Inc. · 2017
- This deviceK222846 AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922667 | Mic Low Profile Gastrostomy Tube | Medical Innovations Corp. | 1993 | 1 |
| −3 | K993138 | Ballard Mic-Key G Low Profile Gastrostomy Replacement Kit | Ballard Medical Products | 1999 | — |
| −2 | K122653 | Mic-Key SF Low Profile Gastrostomy Tube and Accessories | Kimberly-Clark Corporation | 2013 | 1 |
| −1 | K161413 | Low Profile Balloon Feeding Device | Applied Medical Technology, Inc. | 2017 | — |
| 0 (this device) | K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 2 | 0 |
| 2015 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K161413 | Low Profile Balloon Feeding DeviceSummary page 5…Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT III. PREDICATE INFORMATION: Predicate: K161413 (Low Profile Balloon Feeding Device; Applied Medical Technology, Inc.) Secondary Predicate Device: K190923 (Salem Sump Dual Lume… | 2017 |
| * | K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit ConnectionSummary page 5…II Product Code: KNT III. PREDICATE INFORMATION: Predicate: K161413 (Low Profile Balloon Feeding Device; Applied Medical Technology, Inc.) Secondary Predicate Device: K190923 (Salem Sump Dual Lumen Stomach Tube with ENFit Connection; Cardinal Health). Tertiary Predicate Device: K971434 (AMT G-Tube Ball… | 2019 |
| * | K971434 | A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding DeviceSummary page 5…d Medical Technology, Inc.) Secondary Predicate Device: K190923 (Salem Sump Dual Lumen Stomach Tube with ENFit Connection; Cardinal Health). Tertiary Predicate Device: K971434 (AMT G-Tube Balloon Replacement Gastrostomy Feeding Device; Applied Medical Technology, Inc.) ** None of the predicate devices… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- 4 of the 13 ancestors have a recall of any class.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 G-Tube Balloon Gastrostomy Feeding Device is indicated to be used as a percutaneous gastrostomy tube. This device will assist in providing nutrition directly into the stomach through a secured (initial placement) or formed (replacement) stoma in a human patient, 10kg or above, who is unable to consume nutrition by conventional means. The AMT G-Tube Balloon Gastrostomy Feeding Device can also deliver medication and allow for decompression of the stomach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222846 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222846: AMT G-Tube Balloon 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/K222846
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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