510(k) · Decided
DecidedCompat Gastrostomy/Jejunostomy Feeding Tube Kit (088000)
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 Mar 18, 1997 as substantially equivalent to K853353 (Superior Healthcare Group, Inc., 1985) after an 89-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.
- Decided
- Mar 18, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K853353 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK853353 88000 Gastrostomy-Jejunal Feeding Tube KitSuperior Healthcare Group, Inc. · 1985
- This deviceK965087 Compat Gastrostomy/Jejunostomy Feeding Tube Kit (088000)Sandoz Nutrition · 1997
- Descendant · cites it directly · 0 of its ownK071191 Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube KitNovartis Nutrition Corp. · 2007
Most influential descendants
Showing 1 of 1 · See all- K071191Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube KitNovartis Nutrition Corp. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853353 | 88000 Gastrostomy-Jejunal Feeding Tube Kit | Superior Healthcare Group, Inc. | 1985 | — |
| 0 (this device) | K965087 | Compat Gastrostomy/Jejunostomy Feeding Tube Kit (088000) | Sandoz Nutrition | 1997 | — |
| +1 | K071191 | Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube Kit | Novartis Nutrition Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K853353 | 88000 Gastrostomy-Jejunal Feeding Tube Kit Our OCR of the scanned summary read K853351, FDA’s number for Ohmeda Heat Reflecting Patch (Ohmeda Medical). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Sandoz Nutrition #088000 Surgical Gastrostomy/Jejunostomy Feeding…”. | 1985 |
| † | K961664 | Compat Nasojejunal Feeding Tube | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071191 | Novartis Compat Surgical Gastrostomy Jejunostomy Feeding Tube Kit | 2007 | 0 |
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, K071191 (Novartis Nutrition Corp., 2007) has gone furthest, with 0 descendants 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 Surgical Gastrostomy/Jejunostomy Feeding Tube Kit provides for the delivery of enteral formula through a surgically placed Gastrostomy/Jejunostomy feeding tube. Jejunal feeding us used when patients require feeding past the stomach directly into the jejunum. This method is used to enhance the absorption of nutrients and minimize the risks of gastric feeding including gastric reflux and 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/K965087 · printed Nov 4, 2026
Cite this page
510(k) Report. “K965087: Compat Gastrostomy/Jejunostomy Feeding Tube Kit (088000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965087
Report an extraction error
Are you the manufacturer?
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