510(k) · Cleared
ClearedKangaroo Feeding Tube with IRIS Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien (Dba Medtronic) · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on May 16, 2017 as substantially equivalent to K123555 (Covidien, 2014) after a 200-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- May 16, 2017
- Review
- 200 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K831868 (1983). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK831868 Dobbhoff Feeding Tube W/Hydromer LubBiosearch Medical Products, Inc. · 1983
- 2 generations backK112511 Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall · 2012
- 1 generation backK123555 Kangaroo Feeding Tubes with Iris TechnologyCovidien · 2014
- This deviceK163002 Kangaroo Feeding Tube with IRIS TechnologyCovidien (Dba Medtronic) · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K831868 | Dobbhoff Feeding Tube W/Hydromer Lub | Biosearch Medical Products, Inc. | 1983 | — |
| −2 | K112511 | Dobbhoff Dual Port Feeding Tube | Covidien Lp, Formerly Registered AS Kendall | 2012 | — |
| −1 | K123555 | Kangaroo Feeding Tubes with Iris Technology | Covidien | 2014 | — |
| 0 (this device) | K163002 | Kangaroo Feeding Tube with IRIS Technology | Covidien (Dba Medtronic) | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K123555 | Kangaroo Feeding Tubes with Iris TechnologySummary page 4…Code: KNT PIF (Secondary) Class: II Identification of Predicate Device: 510(k) Number K123555 Device Description Kangaroo™ Feeding Tube with IRIS Technology Submitter Covidien Device Descrip… | 2014 |
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 34 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K123555.
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 Kangaroo™ Feeding Tube with IRIS Technology utilizes a video stream to aid a trained user during placement into the stomach or small bowels for the administration of nutrition, fluids, and medications by the naso-enteric route for patients aged 18 years and older who have an intact gastrointestinal tract, but are physically unable to manage nutritional intake through normal mastication and deglutition. Prior to commencing administration, confirm correct tube placement per institutional protocol. Placement of the tip of the device into the small bowel should only be attempted by clinicians with expertise in small bowel placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163002: Kangaroo Feeding Tube with IRIS Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163002
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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