510(k) · Cleared
ClearedJejenostomy Feeding Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FPD Tube, Feeding
Cleared on Aug 20, 1997 after an 89-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Aug 20, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- FPD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK971906 Jejenostomy Feeding TubeBoston Scientific Corp · 1997
- Descendant · cites it directly · 4 of its ownK072476 Through-the-Peg (TTP) Jejunostomy Tube KitBoston Scientific Corporation · 2007
- Descendant · 2 generations on · 2 of its ownK081739 2-Port Through-the-Peg (TTP) Jejunostomy Tube KitBoston Scientific Corp · 2008
- Descendant · 3 generations on · 1 of its ownK133096 Abb Vie JAbbVie, Inc. · 2014
- Descendant · 4 generations on · 0 of its ownK142816 AbbVie JAbbVie, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK091340 Through the -Peg (TTP) Jejunal Feeding Tube Kit, Model…Boston Scientific Corp · 2009
Most influential descendants
Showing 5 of 5 · See all- K072476Through-the-Peg (TTP) Jejunostomy Tube KitBoston Scientific Corporation · 2007 · cites it directly4descendants
- K0817392-Port Through-the-Peg (TTP) Jejunostomy Tube KitBoston Scientific Corp · 2008 · 2 generations on2descendants
- K133096Abb Vie JAbbVie, Inc. · 2014 · 3 generations on1descendant
- K142816AbbVie JAbbVie, Inc. · 2015 · 4 generations on0descendants
- K091340Through the -Peg (TTP) Jejunal Feeding Tube Kit, Model M00566320,M00566330, M00566340…Boston Scientific Corp · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971906 | Jejenostomy Feeding Tube | Boston Scientific Corp | 1997 | — |
| +1 | K072476 | Through-the-Peg (TTP) Jejunostomy Tube Kit | Boston Scientific Corporation | 2007 | — |
| +2 | K081739 | 2-Port Through-the-Peg (TTP) Jejunostomy Tube Kit | Boston Scientific Corp | 2008 | — |
| +3 | K133096 | Abb Vie J | AbbVie, Inc. | 2014 | — |
| +4 | K142816 | AbbVie J | AbbVie, Inc. | 2015 | — |
| +2 | K091340 | Through the -Peg (TTP) Jejunal Feeding Tube Kit, Model M00566320,M00566330… | Boston Scientific Corp | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 FPD? 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 FPD device
- #1 K243361 Nutrifitscore 8.8 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | Bard’s Jejunal Feeding/Gastric Decompression Tube Named without a submission number | |
| * | — | Corpak’s Corflo-Ultra Jejunostomy Tube Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072476 | Through-the-Peg (TTP) Jejunostomy Tube Kit | 2007 | 4 |
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, K072476 (Boston Scientific Corporation, 2007) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FPD devicesFPD Tube, Feeding: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FPD
118in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPD
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPD
10in 2025
MAUDE reports naming product code FPD, 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 | 1 | — | 0 | 19 |
| 2008 | 4 | 76 | 0 | 24 |
| 2009 | 4 | 69 | 0 | 40 |
| 2010 | 4 | 118 | 0 | 21 |
| 2011 | 2 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 32 |
| 2013 | 2 | — | 0 | 38 |
| 2014 | 0 | — | 0 | 64 |
| 2015 | 0 | — | 1 | 55 |
| 2016 | 0 | — | 0 | 102 |
| 2017 | 0 | — | 0 | 34 |
| 2018 | 0 | — | 3 | 30 |
| 2019 | 1 | — | 1 | 19 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 55 |
| 2024 | 1 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TTP J-Tube is indicated for enteral nutritional support and decompression where feeding via the upper gastrointestinal tract is contraindicated. This includes, post upper G.1. tract surgery, radiation therapy, chemotherapy, reflux and other conditions associated with nausea, vomiting and possible aspiration.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971906: Jejenostomy Feeding Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971906
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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