510(k) · Cleared
ClearedBallard Mic-Key G Low Profile Gastrostomy Replacement Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ballard Medical Products · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Oct 20, 1999 as substantially equivalent to K922667 (Medical Innovations Corp., 1993) after a 30-day review. Its family tree reaches back 1 generation to 1993. 5 later devices descend from it.
- Decided
- Oct 20, 1999
- Review
- 30 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922667 (1993). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK922667 Mic Low Profile Gastrostomy TubeMedical Innovations Corp. · 1993 · Recalled
- This deviceK993138 Ballard Mic-Key G Low Profile Gastrostomy Replacement KitBallard Medical Products · 1999
- 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 ownK041034 Skin Level Gastrostomy Tube Kit (Ecsl)Entracare, LLC · 2004
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
- K041034Skin Level Gastrostomy Tube Kit (Ecsl)Entracare, LLC · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922667 | Mic Low Profile Gastrostomy Tube | Medical Innovations Corp. | 1993 | 1 |
| 0 (this device) | K993138 | Ballard Mic-Key G Low Profile Gastrostomy Replacement Kit | Ballard Medical Products | 1999 | — |
| +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 | K041034 | Skin Level Gastrostomy Tube Kit (Ecsl) | Entracare, LLC | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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? (1)
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 |
|---|---|---|---|
| * | K922667 | Mic Low Profile Gastrostomy TubeSummary page 2…strostomy Tube has been shown to be safc and effective for its intended use and equivalent to its predicate device, the MICKEY® “G"™ Low Profile Gastrostomy Tube -510(k) K922667/B, in performance. P 8 C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service S v z i 3 3 o, Food and Dr… | 1993 |
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?
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® G™ Low Profile Gastrostomy Replacement Kit is designed as a replacement Gastrostomy tube. It can be used in any well formed gastric tract where a low profile device is considered desirable.
Gastrostomy tube feeding may be indicated for, patients needing long term enteral support, including but not limited to, feeding, hydrating, medication delivery, and decompressing, secondary to a primary condition relating to the head or neck. These conditions may include:
Stroke
Cancer
Head or neck tumors, injuries, or trauma
Neurological disorders resulting in a chewing or swallowing disorder.
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/K993138 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993138: Ballard Mic-Key G Low Profile Gastrostomy Replacement Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993138
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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