510(k) · Cleared
ClearedCorpak Gastrostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corpak Co. · KGC Tube, Gastro-Enterostomy
Cleared on Jun 11, 1990 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jun 11, 1990
- Review
- 73 days
- Class
- Class II
- Product code
- KGC
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK901501 Corpak Gastrostomy TubeCorpak Co. · 1990
- Descendant · cites it directly · 7 of its ownK962375 Microvasive Balloon Gastrostomy Tube KitBoston Scientific Corp · 1996
- Descendant · 2 generations on · 3 of its ownK083685 Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283…Mri Manufacturing and Research, Inc. · 2009
- Descendant · 3 generations on · 2 of its ownK130674 Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2014
- Descendant · 2 generations on · 2 of its ownK083684 Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc. · 2009
- Descendant · 4 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K962375Microvasive Balloon Gastrostomy Tube KitBoston Scientific Corp · 1996 · cites it directly7descendants
- K083685Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285Mri Manufacturing and Research, Inc. · 2009 · 2 generations on3descendants
- K130674Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2014 · 3 generations on2descendants
- K083684Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc. · 2009 · 2 generations on2descendants
- K180708Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2018 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901501 | Corpak Gastrostomy Tube | Corpak Co. | 1990 | — |
| +1 | K962375 | Microvasive Balloon Gastrostomy Tube Kit | Boston Scientific Corp | 1996 | — |
| +2 | K083685 | Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285 | Mri Manufacturing and Research, Inc. | 2009 | — |
| +3 | K130674 | Entuit Thrive LP Balloon Retention Gastrostomy Feeding Tube | Xeridiem Medical Devices | 2014 | — |
| +2 | K083684 | Endo Vive Standard Replacement Gastrostomy Tube, Model 82XX | Manufacturing & Research, Inc. | 2009 | — |
| +4 | K180708 | Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP… | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGC? 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 KGC device
- #1 K242211 PUMA-G Pediatric Systemscore 10.5 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962375 | Microvasive Balloon Gastrostomy Tube Kit | 1996 | 7 |
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?
- Of its descendants, K962375 (Boston Scientific Corp, 1996) has gone furthest, with 7 descendants of its own.
How does its category compare?
All KGC devicesKGC Tube, Gastro-Enterostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGC
159in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGC
106in 2025
MAUDE reports naming product code KGC, 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 | 0 | — | 0 | 12 |
| 2008 | 2 | — | 0 | 30 |
| 2009 | 1 | — | 5 | 47 |
| 2010 | 0 | — | 6 | 67 |
| 2011 | 0 | — | 0 | 36 |
| 2012 | 1 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 17 |
| 2014 | 0 | — | 0 | 41 |
| 2015 | 0 | — | 1 | 72 |
| 2016 | 0 | — | 0 | 69 |
| 2017 | 1 | — | 0 | 102 |
| 2018 | 0 | — | 0 | 84 |
| 2019 | 3 | 159 | 0 | 90 |
| 2020 | 1 | — | 0 | 118 |
| 2021 | 0 | — | 0 | 73 |
| 2022 | 0 | — | 0 | 51 |
| 2023 | 1 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 87 |
| 2025 | 1 | — | 0 | 106 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K901501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K901501: Corpak Gastrostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901501
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026