510(k) Report

510(k) · Cleared

Cleared

Dobbhoff Feeding Tube W/Hydromer Lub

K831868510(k) TraditionalCleared Jul 12, 198332-day reviewClass II21 CFR 876.5980

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biosearch Medical Products, Inc. · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Jul 12, 1983 after a 32-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.

Decided
Jul 12, 1983
Review
32 days
Class
Class II
Product code
KNT
Recalls
None
Predicates
0

9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2017: 2 descendants cleared2014: 2 descendants cleared2015: 1 descendant cleared2019: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared19801990200020102020
  1. This deviceK831868 Dobbhoff Feeding Tube W/Hydromer LubBiosearch Medical Products, Inc. · 1983
  2. Descendant · cites it directly · 8 of its ownK112511 Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall · 2012
  3. Descendant · 2 generations on · 4 of its ownK123555 Kangaroo Feeding Tubes with Iris TechnologyCovidien · 2014
  4. Descendant · 3 generations on · 2 of its ownK142327 smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015
  5. Descendant · 4 generations on · 1 of its ownK230206 Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc. · 2023
  6. Descendant · 2 generations on · 1 of its ownK141753 Aquarius Nasal Feeding TubeDegania Silicone, Ltd. · 2014

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2012: 12014: 22015: 12017: 22019: 12023: 12024: 1
2012high 2 (2014) · low 0 (2013)2026

Most influential descendants

Showing 5 of 9 · See all
  • K112511Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall · 2012 · cites it directly8descendants
  • K123555Kangaroo Feeding Tubes with Iris TechnologyCovidien · 2014 · 2 generations on4descendants
  • K142327smARTrack Feeding Tube SystemArt Healthcare, Ltd. · 2015 · 3 generations on2descendants
  • K230206Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc. · 2023 · 4 generations on1descendant
  • K141753Aquarius Nasal Feeding TubeDegania Silicone, Ltd. · 2014 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K831868Dobbhoff Feeding Tube W/Hydromer LubBiosearch Medical Products, Inc.1983—
+1K112511Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall2012—
+2K123555Kangaroo Feeding Tubes with Iris TechnologyCovidien2014—
+3K142327smARTrack Feeding Tube SystemArt Healthcare, Ltd.2015—
+4K230206Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc.2023—
+2K141753Aquarius Nasal Feeding TubeDegania Silicone, Ltd.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201420
201510
201720
201910
202310
202410
FIG. 1 — Lineage of K831868, 1983–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112511Dobbhoff Dual Port Feeding TubeCovidien Lp, Formerly Registered AS Kendall20128

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?

  • Of its descendants, K112511 (Covidien Lp, Formerly Registered AS Kendall, 2012) has gone furthest, with 8 descendants of its own.

How does its category compare?

All KNT devices

KNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNT

4in 2025

2007: 102008: 102009: 112010: 122011: 72012: 122013: 72014: 162015: 102016: 62017: 92018: 72019: 102020: 52021: 62022: 72023: 52024: 92025: 42026 (partial year): 3
2007high 16 (2014) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNT

136in 2025

2007: 118 days median2008: 115 days median2009: 102 days median2010: 104 days median2011: 211 days median2012: 107 days median2013: 128 days median2014: 259 days median2015: 140 days median2016: 99 days median2017: 247 days median2018: 149 days median2019: 126 days median2020: 102 days median2021: 121 days median2022: 110 days median2023: 162 days median2024: 103 days median2025: 136 days median2026 (partial year): 105 days median
2007high 259 (2014) · low 99 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNT

13in 2025

2007: 12008: 822009: 92010: 32011: 22012: 12015: 12016: 32017: 42018: 22019: 22020: 12021: 22022: 1, 1 Class I2023: 22025: 132026 (partial year): 20
2007high 82 (2008) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KNT

1,451in 2025

2007: 3002008: 8672009: 8182010: 5172011: 5312012: 5282013: 7472014: 1,0302015: 1,0482016: 1,2512017: 1,6722018: 1,9012019: 1,8382020: 1,6412021: 1,6552022: 1,6502023: 1,8632024: 1,3442025: 1,451
2007high 1,901 (2018) · low 300 (2007)2025

MAUDE reports naming product code KNT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007101181300
20081011582867
2009111029818
2010121043517
201172112531
2012121071528
201371280747
20141625901,030
20151014011,048
201669931,251
2017924741,672
2018714921,901
20191012621,838
2020510211,641
2021612121,655
202271101 (1)1,650
2023516221,863
2024910301,344
20254136131,451
2026310520—
Cite this page

510(k) Report. “K831868: Dobbhoff Feeding Tube W/Hydromer Lub.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K831868

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026