510(k) · Cleared
ClearedKimberly-Clark Mic-Key Low Profile Gastrostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corp. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Dec 10, 2004 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Dec 10, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK043114 Kimberly-Clark Mic-Key Low Profile Gastrostomy TubeKimberly-Clark Corp. · 2004
- Descendant · cites it directly · 3 of its ownK122653 Mic-Key SF Low Profile Gastrostomy Tube and AccessoriesKimberly-Clark Corporation · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK161413 Low Profile Balloon Feeding DeviceApplied Medical Technology, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK222846 AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK173955 Mic-Key* SF Over-the-Wire Stoma Measuring DeviceHalyard Health, Inc. · 2018
- 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 5 of 5 · See all- K122653Mic-Key SF Low Profile Gastrostomy Tube and AccessoriesKimberly-Clark Corporation · 2013 · cites it directly3descendants
- K161413Low Profile Balloon Feeding DeviceApplied Medical Technology, Inc. · 2017 · 2 generations on1descendant
- K222846AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. · 2023 · 3 generations on0descendants
- K173955Mic-Key* SF Over-the-Wire Stoma Measuring DeviceHalyard Health, Inc. · 2018 · 2 generations on0descendants
- K142297Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S…Xeridiem (Formerly Mri) · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043114 | Kimberly-Clark Mic-Key Low Profile Gastrostomy Tube | Kimberly-Clark Corp. | 2004 | — |
| +1 | K122653 | Mic-Key SF Low Profile Gastrostomy Tube and Accessories | Kimberly-Clark Corporation | 2013 | 1 |
| +2 | K161413 | Low Profile Balloon Feeding Device | Applied Medical Technology, Inc. | 2017 | — |
| +3 | K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. | 2023 | — |
| +2 | K173955 | Mic-Key* SF Over-the-Wire Stoma Measuring Device | Halyard Health, Inc. | 2018 | — |
| +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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (5)
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, K122653 (Kimberly-Clark Corporation, 2013) has gone furthest, with 3 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 MIC-KEY Low Profile Gastrostomy Tube is designed as
replacement gastrostomy tube for use in a mature gastric stoma when a low profile device would
benefit the patient.
Gastrostomy tubes are indicated for patients with inability to swallow, other neurological
disorders, and other conditions for which tube feeding would benefit the patient in the judgment
of the physician..
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K043114 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043114: Kimberly-Clark Mic-Key Low Profile Gastrostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043114
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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