510(k) · Cleared
ClearedVygon - Enteral Feeding Tube - Polyurethane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vygon Corp. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on May 2, 1994 after a 531-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- May 2, 1994
- Review
- 531 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK925854 Vygon - Enteral Feeding Tube - PolyurethaneVygon Corp. · 1994
- Descendant · cites it directly · 7 of its ownK020005 Infant Feeding TubesPromedic, Inc. · 2002
- Descendant · 2 generations on · 6 of its ownK052903 Pediatric Feeding TubePromedic, Inc. · 2005
- Descendant · 3 generations on · 5 of its ownK072756 Non-IV Adapter for Infant NG TubePromedic, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK082710 Safechild Enteral Feeding Tube and Accessories and Feeding Tube…Neochild, LLC · 2009
- Descendant · 2 generations on · 2 of its ownK092628 Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K020005Infant Feeding TubesPromedic, Inc. · 2002 · cites it directly7descendants
- K052903Pediatric Feeding TubePromedic, Inc. · 2005 · 2 generations on6descendants
- K072756Non-IV Adapter for Infant NG TubePromedic, Inc. · 2007 · 3 generations on5descendants
- K082710Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension SetNeochild, LLC · 2009 · cites it directly4descendants
- K092628Enteral Feeding Tube and Accessories, Feeding Tube Extension SetAlan Reid · 2010 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925854 | Vygon - Enteral Feeding Tube - Polyurethane | Vygon Corp. | 1994 | — |
| +1 | K020005 | Infant Feeding Tubes | Promedic, Inc. | 2002 | — |
| +2 | K052903 | Pediatric Feeding Tube | Promedic, Inc. | 2005 | — |
| +3 | K072756 | Non-IV Adapter for Infant NG Tube | Promedic, Inc. | 2007 | — |
| +1 | K082710 | Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set | Neochild, LLC | 2009 | — |
| +2 | K092628 | Enteral Feeding Tube and Accessories, Feeding Tube Extension Set | Alan Reid | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
3 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, K020005 (Promedic, Inc., 2002) has gone furthest, with 7 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 | — |
https://510kreport.com/device/K925854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925854: Vygon - Enteral Feeding Tube - Polyurethane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925854
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026