510(k) · Decided
DecidedThrough the -Peg (TTP) Jejunal Feeding Tube Kit, Model M00566320,M00566330, M00566340, M00566350
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 Jun 9, 2009 as substantially equivalent to K072476 (Boston Scientific Corporation, 2007) after a 34-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jun 9, 2009
- Review
- 34 days
- Class
- Class II
- Product code
- FPD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971906 (1997). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971906 | Jejenostomy Feeding Tube | Boston Scientific Corp | 1997 | — |
| −1 | K072476 | Through-the-Peg (TTP) Jejunostomy Tube Kit | Boston Scientific Corporation | 2007 | — |
| 0 (this device) | K091340 | Through the -Peg (TTP) Jejunal Feeding Tube Kit, Model M00566320,M00566330… | Boston Scientific Corp | 2009 | — |
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? (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 |
|---|---|---|---|
| * | K072476 | Through-the-Peg (TTP) Jejunostomy Tube KitSummary page 1…r: 876.5980 Product Code: KNT Classification: Class II 3. Predicate Device: Through-The-PEG (TTP) Jejunostomy Tube Kit K072476 Manufactured by Boston Scientific, Inc. 4. Device Description: The TTP Jejunal Feeding Tube consists of a three-p… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 2 companies; a new generation was cleared every 10.3 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K072476.
How does its category compare?
All FPD devicesFPD Tube, Feeding: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 Through-The-PEG (TTP) Jejunal Feeding 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.
https://510kreport.com/device/K091340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091340: Through the -Peg (TTP) Jejunal Feeding Tube Kit, Model M00566320,M00566330, M00566340, M00566350.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091340
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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