510(k) · Cleared
ClearedKangaroo Feeding Tubes with Iris Technology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Apr 9, 2014 as substantially equivalent to K112511 (Covidien Lp, Formerly Registered AS Kendall, 2012) after a 506-day review. Its family tree reaches back 2 generations to 1983. 4 later devices descend from it.
- Decided
- Apr 9, 2014
- Review
- 506 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K831868 (1983). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK831868 Dobbhoff Feeding Tube W/Hydromer LubBiosearch Medical Products, Inc. · 1983
- 1 generation backK112511 Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall · 2012
- This deviceK123555 Kangaroo Feeding Tubes with Iris TechnologyCovidien · 2014
- Descendant · cites it directly · 2 of its ownK142327 smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK230206 Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK241169 Entarik NI Feeding Tube SystemGravitas Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK163002 Kangaroo Feeding Tube with IRIS TechnologyCovidien (Dba Medtronic) · 2017
Most influential descendants
Showing 4 of 4 · See all- K142327smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015 · cites it directly2descendants
- K230206Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc. · 2023 · 2 generations on1descendant
- K241169Entarik NI Feeding Tube SystemGravitas Medical, Inc. · 2024 · 3 generations on0descendants
- K163002Kangaroo Feeding Tube with IRIS TechnologyCovidien (Dba Medtronic) · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831868 | Dobbhoff Feeding Tube W/Hydromer Lub | Biosearch Medical Products, Inc. | 1983 | — |
| −1 | K112511 | Dobbhoff Dual Port Feeding Tube | Covidien Lp, Formerly Registered AS Kendall | 2012 | — |
| 0 (this device) | K123555 | Kangaroo Feeding Tubes with Iris Technology | Covidien | 2014 | — |
| +1 | K142327 | smARTrack Feeding Tube System | Art Healthcare, Ltd. | 2015 | — |
| +2 | K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | 2023 | — |
| +3 | K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K112511 | Dobbhoff Dual Port Feeding TubeSummary page 1…bes with IRIS Technology c. Identification of Legally Marketed Device(s) * Covidien DOBBHOFFTM Dual Port Feeding Tubes, with and without Flow-Through Stylet, K1 12511 * Corpak CORTRAKTM System, reference predicate for the replacement stylet, K080679 d. Device Brief Description The Ka… | 2012 |
| † | K080679 | Modification to Cortrak Enteral Access Device, Model 20-0900 | 2008 |
What descends from it? (4)
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)
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 31 years and passes through 3 companies; a new generation was cleared every 28.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K142327 (Art Healthcare, Ltd., 2015) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K112511.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 TM 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/K123555 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123555: Kangaroo Feeding Tubes with Iris Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123555
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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