510(k) · Decided
DecidedNasojejunal Feeding Tube W/Gastric Drainage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sandoz Nutrition · FPD Tube, Feeding
Cleared on Feb 25, 1992 after a 210-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 25, 1992
- Review
- 210 days
- Class
- Class II
- Product code
- FPD
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK913407 Nasojejunal Feeding Tube W/Gastric DrainageSandoz Nutrition · 1992
- Descendant · cites it directly · 2 of its ownK961664 Compat Nasojejunal Feeding TubeSandoz Nutrition · 1996
- Descendant · 2 generations on · 1 of its ownK141753 Aquarius Nasal Feeding TubeDegania Silicone, Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK181787 Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding TubesCedic S.R.L. · 2019
Most influential descendants
Showing 3 of 3 · See all- K961664Compat Nasojejunal Feeding TubeSandoz Nutrition · 1996 · cites it directly2descendants
- K141753Aquarius Nasal Feeding TubeDegania Silicone, Ltd. · 2014 · 2 generations on1descendant
- K181787Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding TubesCedic S.R.L. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913407 | Nasojejunal Feeding Tube W/Gastric Drainage | Sandoz Nutrition | 1992 | — |
| +1 | K961664 | Compat Nasojejunal Feeding Tube | Sandoz Nutrition | 1996 | — |
| +2 | K141753 | Aquarius Nasal Feeding Tube | Degania Silicone, Ltd. | 2014 | — |
| +3 | K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes | Cedic S.R.L. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961664 | Compat Nasojejunal Feeding Tube | 1996 | 2 |
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, K961664 (Sandoz Nutrition, 1996) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K913407 · printed Nov 6, 2026
Cite this page
510(k) Report. “K913407: Nasojejunal Feeding Tube W/Gastric Drainage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913407
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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