510(k) · Cleared
ClearedCompat Jejunostomy Tube Kit, Model 088OXX (XX=16,14, or 12)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novartis Nutrition Corp. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jul 26, 1999 as substantially equivalent to K880767 (Medical Innovations Corp., 1988) after a 73-day review. Its family tree reaches back 1 generation to 1988. 1 later device descends from it.
- Decided
- Jul 26, 1999
- Review
- 73 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K880767 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK880767 Mic Needle Jejunostomy Tube KitMedical Innovations Corp. · 1988
- This deviceK991668 Compat Jejunostomy Tube Kit, Model 088OXX (XX=16,14, or 12)Novartis Nutrition Corp. · 1999
- Descendant · cites it directly · 0 of its ownK160567 Barone Jejunostomy Catheter SetCook Incorporated · 2017
Most influential descendants
Showing 1 of 1 · See all- K160567Barone Jejunostomy Catheter SetCook Incorporated · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880767 | Mic Needle Jejunostomy Tube Kit | Medical Innovations Corp. | 1988 | — |
| 0 (this device) | K991668 | Compat Jejunostomy Tube Kit, Model 088OXX (XX=16,14, or 12) | Novartis Nutrition Corp. | 1999 | — |
| +1 | K160567 | Barone Jejunostomy Catheter Set | Cook Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K880767 | Mic Needle Jejunostomy Tube KitSummary page 1…ostomy Tube Kit Jejunostomy Tube Kit Gastrointestinal Tubes and Accessories (per 21CFR 876.5980) Medical Innovations Corp. MIC Jejunostomy Tube #300-014 510(k) Number: K880767 The Jejunostomy Tube is a surgically placed small bowel feeding access port intended for single patient use. The device deliver… | 1988 |
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 |
|---|---|---|---|
| K160567 | Barone Jejunostomy Catheter Set | 2017 | 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, K160567 (Cook Incorporated, 2017) 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 Novartis Nutrition COMPAT Jejunostomy Tube is a surgically placed small bowel feeding access port intended for single patient use. The device delivers enteral solutions and medications directly into the small intestine. When direct access to the small bowel lumen is necessary, the tube may be placed, and positioned within the small bowel using an appropriate technique. It may be permanently fixed to the skin of the outer abdomen using the external retainer provided and suture, or another appropriate fixation technique.
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/K991668 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991668: Compat Jejunostomy Tube Kit, Model 088OXX (XX=16,14, or 12).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991668
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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