510(k) · Cleared
ClearedBarone Jejunostomy Catheter Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on May 18, 2017 as substantially equivalent to K991668 (Novartis Nutrition Corp., 1999) and 1 other predicate after a 444-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- May 18, 2017
- Review
- 444 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K880767 (1988). 3 ancestors in all. 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 | K880767 | Mic Needle Jejunostomy Tube Kit | Medical Innovations Corp. | 1988 | — |
| −1 | K991668 | Compat Jejunostomy Tube Kit, Model 088OXX (XX=16,14, or 12) | Novartis Nutrition Corp. | 1999 | — |
| 0 (this device) | K160567 | Barone Jejunostomy Catheter Set | Cook Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (2)
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 |
|---|---|---|---|
| * | K991668 | Compat Jejunostomy Tube Kit, Model 088OXX (XX=16,14, or 12)Summary page 4…Product Codes OCY Device Class/Classification Panel: Class II, Gastroenterology/Urology Predicate Devices: Primary Predicate: Compat® Jejunostomy Feeding Tube Kit (K991668) Additional Predicate: Flexiflo Laparoscopic Jejunostomy Kit (K925102) Device Description: The Barone Jejunostomy Cathete… | 1999 |
| * | K925102 | Flexiflo Laparoscopic Jejunostomy KitSummary page 4…y/Urology Predicate Devices: Primary Predicate: Compat® Jejunostomy Feeding Tube Kit (K991668) Additional Predicate: Flexiflo Laparoscopic Jejunostomy Kit (K925102) Device Description: The Barone Jejunostomy Catheter Set is comprised of a jejunostomy catheter with a pre-loaded stiffening cann… | 1994 |
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 29 years and passes through 3 companies; a new generation was cleared every 17.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
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 Barone Jejunostomy Catheter Set is intended for patients older than 12 years old requiring jejunal feeding and delivery of medication. The device can be placed via a surgically open or laparoscopic technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160567: Barone Jejunostomy Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160567
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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