510(k) Report

510(k) · Decided

Recalled · Class II · 2016

Amt Low-Profile Transgastric-Jejunal Feeding Tube Kit

K123716510(k) TraditionalDecided Apr 19, 2013136-day reviewClass II21 CFR 876.5980Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Applied Medical Technology, Inc. · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Apr 19, 2013 after a 136-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it. It has been recalled once.

Decided
Apr 19, 2013
Review
136 days
Class
Class II
Product code
KNT
Recalls
1
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2019: 2 descendants cleared2010201520202025
  1. This deviceK123716 Amt Low-Profile Transgastric-Jejunal Feeding Tube KitApplied Medical Technology, Inc. · 2013
  2. Descendant · cites it directly · 0 of its ownK183508 Micro Transgastric-Jejunal Feeding DeviceApplied Medical Technology, Inc. · 2019
  3. Descendant · cites it directly · 0 of its ownK182804 Traditional Length GJ Feeding DeviceApplied Medical Technology, Inc. · 2019

Most influential descendants

Showing 2 of 2 · See all
  • K183508Micro Transgastric-Jejunal Feeding DeviceApplied Medical Technology, Inc. · 2019 · cites it directly0descendants
  • K182804Traditional Length GJ Feeding DeviceApplied Medical Technology, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K123716Amt Low-Profile Transgastric-Jejunal Feeding Tube KitApplied Medical Technology, Inc.2013—
+1K183508Micro Transgastric-Jejunal Feeding DeviceApplied Medical Technology, Inc.2019—
+1K182804Traditional Length GJ Feeding DeviceApplied Medical Technology, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201920
FIG. 1 — Lineage of K123716, 2013–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.8 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

NumberDeviceApplicantDecidedDescendants
K183508Micro Transgastric-Jejunal Feeding DeviceApplied Medical Technology, Inc.20190
K182804Traditional Length GJ Feeding DeviceApplied Medical Technology, Inc.20190

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 26, 2016Class IIZ-1497-2016Employee errorThe firm received complaints that the product is shorter in length than indicated on the label.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K183508 (Applied Medical Technology, Inc., 2019) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KNT devices

KNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · KNT

4in 2025

2007: 102008: 102009: 112010: 122011: 72012: 122013: 72014: 162015: 102016: 62017: 92018: 72019: 102020: 52021: 62022: 72023: 52024: 92025: 42026 (partial year): 3
2007high 16 (2014) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNT

136in 2025

2007: 118 days median2008: 115 days median2009: 102 days median2010: 104 days median2011: 211 days median2012: 107 days median2013: 128 days median2014: 259 days median2015: 140 days median2016: 99 days median2017: 247 days median2018: 149 days median2019: 126 days median2020: 102 days median2021: 121 days median2022: 110 days median2023: 162 days median2024: 103 days median2025: 136 days median2026 (partial year): 105 days median
2007high 259 (2014) · low 99 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNT

13in 2025

2007: 12008: 822009: 92010: 32011: 22012: 12015: 12016: 32017: 42018: 22019: 22020: 12021: 22022: 1, 1 Class I2023: 22025: 132026 (partial year): 20
2007high 82 (2008) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KNT

1,451in 2025

2007: 3002008: 8672009: 8182010: 5172011: 5312012: 5282013: 7472014: 1,0302015: 1,0482016: 1,2512017: 1,6722018: 1,9012019: 1,8382020: 1,6412021: 1,6552022: 1,6502023: 1,8632024: 1,3442025: 1,451
2007high 1,901 (2018) · low 300 (2007)2025

MAUDE reports naming product code KNT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007101181300
20081011582867
2009111029818
2010121043517
201172112531
2012121071528
201371280747
20141625901,030
20151014011,048
201669931,251
2017924741,672
2018714921,901
20191012621,838
2020510211,641
2021612121,655
202271101 (1)1,650
2023516221,863
2024910301,344
20254136131,451
2026310520—

What is it indicated for?

The AMT Transgastric-Jejunal feeding tube is indicated for use in patients who cannot absorb adequate nutrition through the stomach, who have intestinal motility problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of aspiration, or in those who have had previous esophagectomy or gastrectomy. The use of this tube is also clinically indicated when simultaneous gastric decompression and jejunal feeding are needed. This includes patients in whom malnutrition already exists, or may result, secondary to concurrent conditions.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K123716: Amt Low-Profile Transgastric-Jejunal Feeding Tube Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123716

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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