510(k) · Cleared
ClearedCompat Nasojejunal Feeding Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sandoz Nutrition · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Oct 4, 1996 as substantially equivalent to K913407 (Sandoz Nutrition, 1992) after a 157-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Oct 4, 1996
- Review
- 157 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K913407 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK913407 Nasojejunal Feeding Tube W/Gastric DrainageSandoz Nutrition · 1992
- This deviceK961664 Compat Nasojejunal Feeding TubeSandoz Nutrition · 1996
- Descendant · cites it directly · 1 of its ownK141753 Aquarius Nasal Feeding TubeDegania Silicone, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK181787 Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding TubesCedic S.R.L. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K913407 | Nasojejunal Feeding Tube W/Gastric Drainage | Sandoz Nutrition | 1992 | — |
| 0 (this device) | K961664 | Compat Nasojejunal Feeding Tube | Sandoz Nutrition | 1996 | — |
| +1 | K141753 | Aquarius Nasal Feeding Tube | Degania Silicone, Ltd. | 2014 | — |
| +2 | 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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 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 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 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K913407 | Nasojejunal Feeding Tube W/Gastric DrainageSummary page 1…the Sandoz Nutrition #082301 Nasojejunal Feeding Tube With Gastric Drainage and the Sandoz Nutrition #082303 Nasojejunal Feeding Tube 1legally marketed under 510 (k) : K913407/B Description of the device that is the subject of this 510(K). A Nasojejunal Feeding Tube with or without Gastric Drainage. St… | 1992 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141753 | Aquarius Nasal Feeding Tube | 2014 | 1 |
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, K141753 (Degania Silicone, Ltd., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, 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 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
The Sandoz Nutrition #082302 NFG Tube is intended for use with patients who require both enteral feeding and gastric suction simultaneously. The Sandoz Nutrition #082304 NF Tube is intended for use with patients who require only enteral feeding. Indications for such medical and post-surgical treatments may include surgical problems, prolonged artificial ventilation, central nervous system trauma, and others. The placement of the device in patients can be accomplished intraoperatively at laparotomy wusing standard surgical techniques.
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/K961664 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961664: Compat Nasojejunal Feeding Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961664
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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