510(k) · Cleared
ClearedMedicina Enteral Feeding Tubes and Accessories Model MGX/YY
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxter Catheters · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jun 14, 2010 as substantially equivalent to K060944 (Vygon Corp., 2006) and 2 other predicates after a 122-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Jun 14, 2010
- Review
- 122 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K945012 (1995). 7 ancestors in all, the oldest K820176 (1982). No later device cites it as a predicate yet.
- Root · 3 generations backK945012 Catco Nutritional CatheterCatco Medical, Inc. · 1995
- 2 generations backK072881 NEOMED Enteral FEEDING TUBENeomed, Inc. · 2008
- 1 generation backK082238 Neomed Polyurethane Feeding TubeNeomed, Inc. · 2008 · Recalled
- This deviceK100366 Medicina Enteral Feeding Tubes and Accessories Model MGX/YYMaxter Catheters · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945012 | Catco Nutritional Catheter | Catco Medical, Inc. | 1995 | — |
| −2 | K072881 | NEOMED Enteral FEEDING TUBE | Neomed, Inc. | 2008 | — |
| −1 | K082238 | Neomed Polyurethane Feeding Tube | Neomed, Inc. | 2008 | 1 |
| 0 (this device) | K100366 | Medicina Enteral Feeding Tubes and Accessories Model MGX/YY | Maxter Catheters | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K060944 | Nutrisafe 2Summary page 1…and accessory devices Class: I Predicate devices: 510k) number: K(060944 Manufacturer: Vygon Corporation Trade n… | 2006 |
| * | K072881 | NEOMED Enteral FEEDING TUBESummary page 1…Corporation Trade name: Nutrisafe 2 510k) number: K(072881 Manufacturer: Neomed Trade name:… | 2008 |
| * | K082238 | Neomed Polyurethane Feeding TubeSummary page 1…Trade name: Neomed Enteral Feeding tube 510k) number: K(082238 Manufacturer: Neomned Trade name:… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 6 other devices also cite its predicate K060944.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
MEDICINA enteral feeding tubes and their accessories are dedicated to the nasogastric and orogastric administration of liquid nutritional media, through the gastro intestinal tract of neonatal and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100366: Medicina Enteral Feeding Tubes and Accessories Model MGX/YY.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100366
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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