510(k) · Cleared
ClearedMicrovasive Balloon Gastrostomy Tube Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Sep 4, 1996 as substantially equivalent to K951489 (Manufacturing & Research, Inc., 1995) and 1 other predicate after a 76-day review. Its family tree reaches back 1 generation to 1990. 7 later devices descend from it.
- Decided
- Sep 4, 1996
- Review
- 76 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K901501 (1990). 2 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK901501 Corpak Gastrostomy TubeCorpak Co. · 1990
- This deviceK962375 Microvasive Balloon Gastrostomy Tube KitBoston Scientific Corp · 1996
- Descendant · cites it directly · 3 of its ownK083685 Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283…Mri Manufacturing and Research, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK130674 Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2014
- Descendant · cites it directly · 2 of its ownK083684 Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc. · 2009
- Descendant · 3 generations on · 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 · 1 of its ownK130611 Entuit Thrive Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K083685Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285Mri Manufacturing and Research, Inc. · 2009 · cites it directly3descendants
- K130674Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2014 · 2 generations on2descendants
- K083684Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc. · 2009 · cites it directly2descendants
- K180708Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2018 · 3 generations on1descendant
- K130611Entuit Thrive Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901501 | Corpak Gastrostomy Tube | Corpak Co. | 1990 | — |
| 0 (this device) | 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 | — |
| +2 | K130674 | Entuit Thrive LP Balloon Retention Gastrostomy Feeding Tube | Xeridiem Medical Devices | 2014 | — |
| +1 | K083684 | Endo Vive Standard Replacement Gastrostomy Tube, Model 82XX | Manufacturing & Research, Inc. | 2009 | — |
| +3 | K180708 | Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP… | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2018 | — |
| +2 | K130611 | Entuit Thrive Balloon Retention Gastrostomy Feeding Tube | Xeridiem Medical Devices | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K951489 | Mri's All Silicone Gastrostomy TubeSummary page 3…AL GT GASTROSTOMY TUBES Microvasive MRI All Silicone Corpak Medsystems Balloon Gastrostomy | Gastrostomy Tube CorfloTM-Dual GT Tube Kit Gastrostomy Tubes (This 510(k)) (K951489) (K901501) USE Indication Feeding, medication, Feeding, Feeding and gastric medication, gastric medication decompression decompre… | 1995 |
| * | K901501 | Corpak Gastrostomy TubeSummary page 3…TROSTOMY TUBES Microvasive MRI All Silicone Corpak Medsystems Balloon Gastrostomy | Gastrostomy Tube CorfloTM-Dual GT Tube Kit Gastrostomy Tubes (This 510(k)) (K951489) (K901501) USE Indication Feeding, medication, Feeding, Feeding and gastric medication, gastric medication decompression decompression Rout… | 1990 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K083685 (Mri Manufacturing and Research, Inc., 2009) has gone furthest, with 3 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 Balloon Gastrostomy Tube Kit is indicated for use in percutaneous placement of a gastrostomy tube for feeding and/or medication in conjunction with an established gastrostomy tract, or using a Stamm Procedure. The gastrostomy tube may also be used for gastric decompression
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/K962375 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962375: Microvasive Balloon Gastrostomy Tube Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962375
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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