510(k) · Cleared
ClearedMcLean-Ring Enteral Feeding Tube Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Oct 11, 2019 as substantially equivalent to K160509 (Cook Incorporated, 2017) after a 267-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Oct 11, 2019
- Review
- 267 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K874393 (1987). No later device cites it as a predicate yet.
- Root · 3 generations backK874393 Enteral Feeding TubeWilson-Cook Medical, Inc. · 1987 · Recalled
- 2 generations backK043203 Wilson-Cook Enteral Feeding Tube, Tiger Tube Enteral Feeding TubeWilson-Cook Medical, Inc. · 2005 · Recalled
- 1 generation backK160509 Tiger 2 Self-Advancing Nasal Jejunal Feeding TubeCook Incorporated · 2017
- This deviceK190084 McLean-Ring Enteral Feeding Tube SetCook Incorporated · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874393 | Enteral Feeding Tube | Wilson-Cook Medical, Inc. | 1987 | 1 |
| −2 | K043203 | Wilson-Cook Enteral Feeding Tube, Tiger Tube Enteral Feeding Tube | Wilson-Cook Medical, Inc. | 2005 | 1 |
| −1 | K160509 | Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube | Cook Incorporated | 2017 | — |
| 0 (this device) | K190084 | McLean-Ring Enteral Feeding Tube Set | Cook Incorporated | 2019 | — |
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 |
|---|---|---|---|
| * | K160509 | Tiger 2 Self-Advancing Nasal Jejunal Feeding TubeSummary page 4…logy Predicate Device: The McLean-Ring Enteral Feeding Tube Set is substantially equivalent to the following device: Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube (K160509, Cook Incorporated) cleared on May 18, 2017. Device Description: The McLean-Ring Nasojejunal Feeding Tube Set is composed of a… | 2017 |
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 32 years and passes through 2 companies; a new generation was cleared every 12.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 McLean-Ring Nasojejunal Feeding Tube Set is intended for enteral feeding and medication in adult and pediatric populations. The device is intended to be used in the treatment of the following pediatric subgroups: children and adolescents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190084: McLean-Ring Enteral Feeding Tube Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190084
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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