510(k) · Cleared
ClearedEndo Vive Standard Replacement Gastrostomy Tube, Model 82XX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manufacturing & Research, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Feb 5, 2009 as substantially equivalent to K962375 (Boston Scientific Corp, 1996) and 1 other predicate after a 55-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it.
- Decided
- Feb 5, 2009
- Review
- 55 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K901501 (1990). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK901501 Corpak Gastrostomy TubeCorpak Co. · 1990
- 1 generation backK962375 Microvasive Balloon Gastrostomy Tube KitBoston Scientific Corp · 1996
- This deviceK083684 Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK130611 Entuit Thrive Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2013
- Descendant · 2 generations on · 0 of its ownK171347 Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit…Xeridiem Medical Devices · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901501 | Corpak Gastrostomy Tube | Corpak Co. | 1990 | — |
| −1 | K962375 | Microvasive Balloon Gastrostomy Tube Kit | Boston Scientific Corp | 1996 | — |
| 0 (this device) | K083684 | Endo Vive Standard Replacement Gastrostomy Tube, Model 82XX | Manufacturing & Research, Inc. | 2009 | — |
| +1 | K130611 | Entuit Thrive Balloon Retention Gastrostomy Feeding Tube | Xeridiem Medical Devices | 2013 | — |
| +2 | K171347 | Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection… | Xeridiem Medical Devices | 2017 | — |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K962375 | Microvasive Balloon Gastrostomy Tube KitSummary page 1…erostomy Classification Name: Tube, Gastro-enterostomy, product code KNT Predicate device: Microvasive Balloon Gastrostomy Tube Kit, K962375 EndoViveTM Low Profile Button Replacement Gastrostomy Tube,… | 1996 |
| * | K014297 | Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button Replacement…Summary page 1…oon Gastrostomy Tube Kit, K962375 EndoViveTM Low Profile Button Replacement Gastrostomy Tube, K014297 Reason for submission: Not previously marketed in the USA Device Description and Materials: The EndoViveTM Standa… | 2002 |
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 |
|---|---|---|---|
| K130611 | Entuit Thrive Balloon Retention Gastrostomy Feeding Tube | 2013 | 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 19 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K130611 (Xeridiem Medical Devices, 2013) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K962375.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 EndoViveTM Standard Replacement Gastrostomy 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. Typical uses include the replacement of existing gastrostomy feeding tubes. In addition, the 20F tube is also used for the replacement of initial placement jejunostromy feeding tubes. The replacement tube may also be used for decompression.
Note: Only the 20F tube is indicated for jejunal replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083684 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083684: Endo Vive Standard Replacement Gastrostomy Tube, Model 82XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083684
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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