510(k) · Decided
Recalled · Class II · 2020Mic-Key SF Low Profile Gastrostomy Tube and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corporation · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jun 26, 2013 as substantially equivalent to K043114 (Kimberly-Clark Corp., 2004) and 1 other predicate after a 299-day review. Its family tree reaches back 2 generations to 1993. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 26, 2013
- Review
- 299 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K922667 (1993). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK922667 Mic Low Profile Gastrostomy TubeMedical Innovations Corp. · 1993 · Recalled
- 1 generation backK993138 Ballard Mic-Key G Low Profile Gastrostomy Replacement KitBallard Medical Products · 1999
- This deviceK122653 Mic-Key SF Low Profile Gastrostomy Tube and AccessoriesKimberly-Clark Corporation · 2013
- Descendant · cites it directly · 1 of its ownK161413 Low Profile Balloon Feeding DeviceApplied Medical Technology, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK222846 AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK173955 Mic-Key* SF Over-the-Wire Stoma Measuring DeviceHalyard Health, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K161413Low Profile Balloon Feeding DeviceApplied Medical Technology, Inc. · 2017 · cites it directly1descendant
- K222846AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. · 2023 · 2 generations on0descendants
- K173955Mic-Key* SF Over-the-Wire Stoma Measuring DeviceHalyard Health, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922667 | Mic Low Profile Gastrostomy Tube | Medical Innovations Corp. | 1993 | 1 |
| −1 | K993138 | Ballard Mic-Key G Low Profile Gastrostomy Replacement Kit | Ballard Medical Products | 1999 | — |
| 0 (this device) | K122653 | Mic-Key SF Low Profile Gastrostomy Tube and Accessories | Kimberly-Clark Corporation | 2013 | — |
| +1 | K161413 | Low Profile Balloon Feeding Device | Applied Medical Technology, Inc. | 2017 | — |
| +2 | K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | Applied Medical Technology, Inc. | 2023 | — |
| +1 | K173955 | Mic-Key* SF Over-the-Wire Stoma Measuring Device | Halyard Health, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K043114 | Kimberly-Clark Mic-Key Low Profile Gastrostomy TubeSummary page 1…FeedingTubes KNT Class Il 21 CFR 876.5980 Gastrointestinal tube and accessories The Kimberly-Clark* MIC-KEY Low Profile Gastrostomy Tube and accessories cleared under K043114 and K993138. Low profile Gastrostomy feeding tube and accessories to facilitate nutrition, medication delivery, and gastric deco… | 2004 |
| * | K993138 | Ballard Mic-Key G Low Profile Gastrostomy Replacement KitSummary page 1…KNT Class Il 21 CFR 876.5980 Gastrointestinal tube and accessories The Kimberly-Clark* MIC-KEY Low Profile Gastrostomy Tube and accessories cleared under K043114 and K993138. Low profile Gastrostomy feeding tube and accessories to facilitate nutrition, medication delivery, and gastric decompression fo… | 1999 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2020 | Class II | Z-2969-2020 | Under Investigation by firm | Devices had cracked or detached from the feeding tube body |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 13.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K161413 (Applied Medical Technology, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K043114.
How does its category compare?
All KNT devicesKNT 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
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 Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube and Accessories are indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma. Kimberly-Clark* MIC-KEY* SF Continuous Feed Extension Set is indicated for use with the…
Read the full statement (157 words)
The Kimberly-Clark* MIC-KEY* SF Low Profile Gastrostomy Tube and Accessories are indicated for use in patients who require long term feeding, are unable to tolerate oral feeding, who are at low risk for aspiration, require gastric decompression and/or medication delivered directly into the stomach through a secured (initial placement) or formed (replacement) stoma.
Kimberly-Clark* MIC-KEY* SF Continuous Feed Extension Set is indicated for use with the MIC-KEY* SF Low Profile Gastrostomy Tube to facilitate nutrition, medication delivery, and gastric decompression.
Kimberly-Clark* MIC-KEY* SF Bolus Feed Extension Set is indicated for use with the MIC-KEY* SF Low Profile Gastrostomy Tube to facilitate nutrition, medication delivery, and gastric decompression.
Kimberly-Clark* MIC-KEY* SF Patient Starter Kit is indicated to provide necessary components to begin enteral feeding after placement of the Kimberly-Clark* MIC-KEY* SF Gastrostomy Tube.
Kimberly-Clark* MIC-KEY* SF Over-the-Wire Stoma Measuring Device is indicated for measuring the length of a stoma prior to placement of a low profile feeding tube.
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/K122653 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122653: Mic-Key SF Low Profile Gastrostomy Tube and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122653
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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