510(k) · Cleared
Recalled · Class II · 2025Wilson-Cook Enteral Feeding Tube, Tiger Tube Enteral Feeding Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on May 11, 2005 as substantially equivalent to K874393 (Wilson-Cook Medical, Inc., 1987) after a 174-day review. Its family tree reaches back 1 generation to 1987. 3 later devices descend from it. It has been recalled once.
- Decided
- May 11, 2005
- Review
- 174 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874393 (1987). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK874393 Enteral Feeding TubeWilson-Cook Medical, Inc. · 1987 · Recalled
- This deviceK043203 Wilson-Cook Enteral Feeding Tube, Tiger Tube Enteral Feeding TubeWilson-Cook Medical, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK160509 Tiger 2 Self-Advancing Nasal Jejunal Feeding TubeCook Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK201322 Entuit Nasal Jejunal Feeding TubeWilson-Cook Medical, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK190084 McLean-Ring Enteral Feeding Tube SetCook Incorporated · 2019
Most influential descendants
Showing 3 of 3 · See all- K160509Tiger 2 Self-Advancing Nasal Jejunal Feeding TubeCook Incorporated · 2017 · cites it directly1descendant
- K201322Entuit Nasal Jejunal Feeding TubeWilson-Cook Medical, Inc. · 2020 · cites it directly0descendants
- K190084McLean-Ring Enteral Feeding Tube SetCook Incorporated · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874393 | Enteral Feeding Tube | Wilson-Cook Medical, Inc. | 1987 | 1 |
| 0 (this device) | K043203 | Wilson-Cook Enteral Feeding Tube, Tiger Tube Enteral Feeding Tube | Wilson-Cook Medical, Inc. | 2005 | — |
| +1 | K160509 | Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube | Cook Incorporated | 2017 | — |
| +1 | K201322 | Entuit Nasal Jejunal Feeding Tube | Wilson-Cook Medical, Inc. | 2020 | — |
| +2 | K190084 | McLean-Ring Enteral Feeding Tube Set | Cook Incorporated | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K874393 | Enteral Feeding TubeSummary page 1…assification: 21 CFR § 876.5980. 78 KNIT PREDICATE DEVICES: Wilson-Cook Enteral Feeding Tube (K874393) INTENDED USE: This device isintended to provide short-term… | 1987 |
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 |
|---|---|---|---|---|
| Dec 15, 2025 | Class II | Z-1298-2026 | Employee error | Nasal feeding tube packaged without the nasal transfer tube component. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K160509 (Cook Incorporated, 2017) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The Wilson-Cook Nasal Jejunal Feeding Tube and Nasal Jejunal Feeding Tube with Flaps are intended to provide short-term enteral access for delivery of nutrition and/or medications to the small bowel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043203: Wilson-Cook Enteral Feeding Tube, Tiger Tube Enteral Feeding Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043203
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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