510(k) · Cleared
ClearedLow Profile Balloon 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 Feb 9, 2017 as substantially equivalent to K122653 (Kimberly-Clark Corporation, 2013) after a 262-day review. Its family tree reaches back 3 generations to 1993. 1 later device descends from it.
- Decided
- Feb 9, 2017
- Review
- 262 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922667 (1993). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK922667 Mic Low Profile Gastrostomy TubeMedical Innovations Corp. · 1993 · Recalled
- 2 generations backK993138 Ballard Mic-Key G Low Profile Gastrostomy Replacement KitBallard Medical Products · 1999
- 1 generation backK122653 Mic-Key SF Low Profile Gastrostomy Tube and AccessoriesKimberly-Clark Corporation · 2013 · Recalled
- This deviceK161413 Low Profile Balloon Feeding DeviceApplied Medical Technology, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK222846 AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222846AMT G-Tube Balloon Gastrostomy Feeding DeviceApplied Medical Technology, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922667 | Mic Low Profile Gastrostomy Tube | Medical Innovations Corp. | 1993 | 1 |
| −2 | 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 |
| 0 (this device) | K161413 | Low Profile Balloon Feeding Device | Applied Medical Technology, Inc. | 2017 | — |
| +1 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K122653 | Mic-Key SF Low Profile Gastrostomy Tube and AccessoriesSummary page 4…Review Panel: Gastroenterology and Urology Primary Predicate: Kimberly-Clark MIC-KEY SF Low Profile Gastrostomy (K122653) Predicate Reference Device: Kimberly-Clark MIC-KEY Low Profile Gastrostomy Tube Device: (K… | 2013 |
| † | K043114 | Kimberly-Clark Mic-Key Low Profile Gastrostomy Tube | 2004 |
| † | K945618 | Gastrointestinal Tubes & Accessories | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222846 | AMT G-Tube Balloon Gastrostomy Feeding Device | 2023 | 0 |
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 24 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K222846 (Applied Medical Technology, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K122653.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Low Profile Balloon Feeding Device is 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. The Low Profile Balloon Feeding Device is intended for all age groups.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161413 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161413: Low Profile Balloon Feeding Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161413
Report an extraction error
Are you the manufacturer?
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