510(k) Report

510(k) · Decided

Decided

Through-the-Peg (TTP) Jejunostomy Tube Kit

K072476510(k) TraditionalDecided Dec 14, 2007101-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

Boston Scientific Corporation · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Dec 14, 2007 as substantially equivalent to K971906 (Boston Scientific Corp, 1997) after a 101-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.

Decided
Dec 14, 2007
Review
101 days
Class
Class II
Product code
KNT
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K971906 (1997). 4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2008: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant clearedK971906 · Jejenostomy Feeding Tube · Boston Scientific Corp · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K971906 · Jejenostomy Feeding Tube · Boston Scientific Corp · 19970
  1. Root · 1 generation backK971906 Jejenostomy Feeding TubeBoston Scientific Corp · 1997
  2. This deviceK072476 Through-the-Peg (TTP) Jejunostomy Tube KitBoston Scientific Corporation · 2007
  3. Descendant · cites it directly · 2 of its ownK081739 2-Port Through-the-Peg (TTP) Jejunostomy Tube KitBoston Scientific Corp · 2008
  4. Descendant · 2 generations on · 1 of its ownK133096 Abb Vie JAbbVie, Inc. · 2014
  5. Descendant · 3 generations on · 0 of its ownK142816 AbbVie JAbbVie, Inc. · 2015
  6. Descendant · cites it directly · 0 of its ownK091340 Through the -Peg (TTP) Jejunal Feeding Tube Kit, Model…Boston Scientific Corp · 2009

Most influential descendants

Showing 4 of 4 · See all
  • K0817392-Port Through-the-Peg (TTP) Jejunostomy Tube KitBoston Scientific Corp · 2008 · cites it directly2descendants
  • K133096Abb Vie JAbbVie, Inc. · 2014 · 2 generations on1descendant
  • K142816AbbVie JAbbVie, Inc. · 2015 · 3 generations on0descendants
  • K091340Through the -Peg (TTP) Jejunal Feeding Tube Kit, Model M00566320,M00566330, M00566340…Boston Scientific Corp · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971906Jejenostomy Feeding TubeBoston Scientific Corp1997—
0 (this device)K072476Through-the-Peg (TTP) Jejunostomy Tube KitBoston Scientific Corporation2007—
+1K0817392-Port Through-the-Peg (TTP) Jejunostomy Tube KitBoston Scientific Corp2008—
+2K133096Abb Vie JAbbVie, Inc.2014—
+3K142816AbbVie JAbbVie, Inc.2015—
+1K091340Through the -Peg (TTP) Jejunal Feeding Tube Kit, Model M00566320,M00566330…Boston Scientific Corp2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201410
201510
FIG. 1 — Lineage of K072476, 1997–2015Source: 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), 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. #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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K971906Jejenostomy Feeding Tube
Summary page 1
…n Number: 876.5980 Product Code: KNT Classification: Class II 3. Predicate Device(s): > Boston Scientific Corporation's TTP Jejunostomy Tube Kit, K971906 > Wilson-Cook Medical's Nasal Jejunal Feeding Tube, Nasal Feeding Tube with Flaps, K042303 Both predic…
Boston Scientific Corp1997—
Kept off the family treeK042303FDA’s K042303 is Vitros Immunodiagnostic Products Anti-HBS Controls
Our reading of the summary gave K042303, FDA’s number for Vitros Immunodiagnostic Products Anti-HBS Controls (Ortho-Clinical Diagnostics). Its FDA name has none of the distinctive words the summary uses for the device it names, “Nasal Jejunal Feeding Tube, Nasal Feeding Tube with Flaps”. Kept off the family tree.
Summary page 1
…> Boston Scientific Corporation's TTP Jejunostomy Tube Kit, K971906 > Wilson-Cook Medical's Nasal Jejunal Feeding Tube, Nasal Feeding Tube with Flaps, K042303 Both predicates are class HIdevices per 21 CFR 878.3610 4. Device Description: The proposed TiP Jejunostomy Tu…
Ortho-Clinical Diagnostics2004—

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K0817392-Port Through-the-Peg (TTP) Jejunostomy Tube KitBoston Scientific Corp20082
K091340Through the -Peg (TTP) Jejunal Feeding Tube Kit, Model M00566320,M00566330, M00566340…Boston Scientific Corp20090

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?

  • Its one ancestor has no recall.
  • Of its descendants, K081739 (Boston Scientific Corp, 2008) has gone furthest, with 2 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. 2007, this device’s year, is highlighted.

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—

What is it indicated for?

The TTP Jejunostomy Tube Kit is intended to provide enteral access for decompression and delivery of nutrition and/or medication.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K072476: Through-the-Peg (TTP) Jejunostomy Tube Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072476

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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