510(k) · Cleared
ClearedDobbhoff Dual Port Feeding Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien Lp, Formerly Registered AS Kendall · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on May 11, 2012 as substantially equivalent to K831868 (Biosearch Medical Products, Inc., 1983) and 1 other predicate after a 255-day review. Its family tree reaches back 1 generation to 1983. 8 later devices descend from it.
- Decided
- May 11, 2012
- Review
- 255 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K831868 (1983). 2 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK831868 Dobbhoff Feeding Tube W/Hydromer LubBiosearch Medical Products, Inc. · 1983
- This deviceK112511 Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall · 2012
- Descendant · cites it directly · 4 of its ownK123555 Kangaroo Feeding Tubes with Iris TechnologyCovidien · 2014
- Descendant · 2 generations on · 2 of its ownK142327 smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015
- Descendant · 3 generations on · 1 of its ownK230206 Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK141753 Aquarius Nasal Feeding TubeDegania Silicone, Ltd. · 2014
- Descendant · 4 generations on · 0 of its ownK241169 Entarik NI Feeding Tube SystemGravitas Medical, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K123555Kangaroo Feeding Tubes with Iris TechnologyCovidien · 2014 · cites it directly4descendants
- K142327smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015 · 2 generations on2descendants
- K230206Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc. · 2023 · 3 generations on1descendant
- K141753Aquarius Nasal Feeding TubeDegania Silicone, Ltd. · 2014 · cites it directly1descendant
- K241169Entarik NI Feeding Tube SystemGravitas Medical, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831868 | Dobbhoff Feeding Tube W/Hydromer Lub | Biosearch Medical Products, Inc. | 1983 | — |
| 0 (this device) | K112511 | Dobbhoff Dual Port Feeding Tube | Covidien Lp, Formerly Registered AS Kendall | 2012 | — |
| +1 | K123555 | Kangaroo Feeding Tubes with Iris Technology | Covidien | 2014 | — |
| +2 | K142327 | smARTrack Feeding Tube System | Art Healthcare, Ltd. | 2015 | — |
| +3 | K230206 | Entarik Feeding Tube System; Entarik Feeding Tube | Gravitas Medical, Inc. | 2023 | — |
| +1 | K141753 | Aquarius Nasal Feeding Tube | Degania Silicone, Ltd. | 2014 | — |
| +4 | K241169 | Entarik NI Feeding Tube System | Gravitas Medical, Inc. | 2024 | — |
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 |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K831868 | Dobbhoff Feeding Tube W/Hydromer LubSummary page 1…ing Tubes c. Identification of Legally Marketed Device(s) *DobbhoffTM Feeding Tubes with Hydromer Lubricant were most recently cleared under notification K831868. *Corpak Medlsystems Corflo® Enteral Feeding Tubes were most recently cleared under notification K083210. d. Devic… | 1983 |
| * | K083210 | Corflo Anti IV Enteral Feeding TubeSummary page 1…e most recently cleared under notification K831868. *Corpak Medlsystems Corflo® Enteral Feeding Tubes were most recently cleared under notification K083210. d. Device Brief Description The DOBBHOFF nasogastric enteral feeding tubes are small bore enteral access catheters. These feed… | 2008 |
What descends from it? (8)
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K123555 (Covidien, 2014) has gone furthest, with 4 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. 2012, 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?
DOBBHOFF Tm Dual Port Feeding Tubes, with and without Flow-Through Stylet, are for
the administration of nutrition, fluids and medications by the naso-enteric route for patients
who have an intact gastrointestinal tract but are physically unable to manage nutritional
intake through normal mastication and deglutition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112511: Dobbhoff Dual Port 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/K112511
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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