510(k) · Cleared
ClearedMedline Gastrostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · KGC Tube, Gastro-Enterostomy
Cleared on Mar 19, 2008 after a 79-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 19, 2008
- Review
- 79 days
- Class
- Class II
- Product code
- KGC
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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
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What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All KGC devicesKGC Tube, Gastro-Enterostomy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Medline Gastrostomy Tube is designed as a percutaneous replacement tube which
is inserted in a well-healed, mature gastric stoma. The device delivers liquid enteral
formula and medications directly into the stomach.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K073718 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073718: Medline Gastrostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073718
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026