510(k) · Cleared
ClearedKangaroo Jejunal Feeding System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sherwood Medical Co. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on May 13, 1996 as substantially equivalent to K900590 (Biosearch Medical Products, Inc., 1990) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- May 13, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900590 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK900590 Biosearch Dobbhoff (R) Gastrotrac Jejunal FeedingBiosearch Medical Products, Inc. · 1990
- This deviceK960677 Kangaroo Jejunal Feeding SystemSherwood Medical Co. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900590 | Biosearch Dobbhoff (R) Gastrotrac Jejunal Feeding | Biosearch Medical Products, Inc. | 1990 | — |
| 0 (this device) | K960677 | Kangaroo Jejunal Feeding System | Sherwood Medical Co. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 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 |
|---|---|---|---|
| * | K900590 | Biosearch Dobbhoff (R) Gastrotrac Jejunal FeedingSummary page 1…d, RAC, Regulatory Affairs Manager The Kangaroo® EntriStar Jejunal Feeding System is substantially equivalent to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube (K900590), and the BioSearch Dobbhoff GastroTrac Jejunal Feeding System, (K900624), both currently manufactured by BioSearch and distribut… | 1990 |
| * | K900624 | Dobbhoff (R) Gastrotrac Jejunal Feeding SystemSummary page 1…ng System is substantially equivalent to the BioSearch Dobbhoff GastroTrac Jejunal Feeding Tube (K900590), and the BioSearch Dobbhoff GastroTrac Jejunal Feeding System, (K900624), both currently manufactured by BioSearch and distributed by Sherwood Medical. Sherwood Medical Company will manufacture this pr… | 1990 |
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?
- None of the 2 ancestors has a recall.
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 | — |
https://510kreport.com/device/K960677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960677: Kangaroo Jejunal Feeding System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960677
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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