510(k) · Cleared
ClearedEntuit Thrive LP Balloon Retention Gastrostomy Feeding Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xeridiem Medical Devices · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jan 13, 2014 as substantially equivalent to K083685 (Mri Manufacturing and Research, Inc., 2009) after a 306-day review. Its family tree reaches back 3 generations to 1990. 2 later devices descend from it.
- Decided
- Jan 13, 2014
- Review
- 306 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K901501 (1990). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK901501 Corpak Gastrostomy TubeCorpak Co. · 1990
- 2 generations backK962375 Microvasive Balloon Gastrostomy Tube KitBoston Scientific Corp · 1996
- 1 generation backK083685 Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283…Mri Manufacturing and Research, Inc. · 2009
- This deviceK130674 Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2014
- Descendant · cites it directly · 1 of its ownK180708 Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2018
- Descendant · 2 generations on · 0 of its ownK232046 Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2023
Most influential descendants
Showing 2 of 2 · See all- K180708Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2018 · cites it directly1descendant
- K232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901501 | Corpak Gastrostomy Tube | Corpak Co. | 1990 | — |
| −2 | K962375 | Microvasive Balloon Gastrostomy Tube Kit | Boston Scientific Corp | 1996 | — |
| −1 | K083685 | Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285 | Mri Manufacturing and Research, Inc. | 2009 | — |
| 0 (this device) | K130674 | Entuit Thrive LP Balloon Retention Gastrostomy Feeding Tube | Xeridiem Medical Devices | 2014 | — |
| +1 | K180708 | Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP… | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2018 | — |
| +2 | K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with… | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K083685 | Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285Summary page 1…Classification Panel: Gastroenterology/Urology Predicate Device Information Trade Name: EndoVive TM Low Profile Replacement Gastrostomy Tube (K083685) Common Name: Gastrostomy Tube Kit (low profile) Classification Name: Tubes, gastrointestinal (a… | 2009 |
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 |
|---|---|---|---|
| K180708 | Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP… | 2018 | 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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K180708 (Xeridiem Medical Devices, A Spectrum Plastics Group Company, 2018) 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. 2014, 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 Entuit Thrive Balloon Retention Gastrostomy Feeding Tube is indicated in adult and pediatric populations for use in percutaneous placement of an Enteral feeding tube for feeding and/or administration of medication in conjunction with an established GI stoma tract. The replacement tube may also be used for gastric decompression.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130674: Entuit Thrive LP Balloon Retention Gastrostomy Feeding Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130674
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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