510(k) · Cleared
Recalled · 2009Button Replacement Gastrostomy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · KGC Tube, Gastro-Enterostomy
Cleared on Jan 18, 1991 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 5 times.
- Decided
- Jan 18, 1991
- Review
- 88 days
- Class
- Class II
- Product code
- KGC
- Recalls
- 5
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 20, 2009 | Not classified | Z-2019-2009 | Equipment maintenance | Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment. |
| Jan 20, 2009 | Not classified | Z-2017-2009 | Equipment maintenance | Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment. |
| Jan 20, 2009 | Not classified | Z-2021-2009 | Equipment maintenance | Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment. |
| Jan 20, 2009 | Not classified | Z-2018-2009 | Equipment maintenance | Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment. |
| Jan 20, 2009 | Not classified | Z-2020-2009 | Equipment maintenance | Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment. |
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.
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/K904779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K904779: Button Replacement Gastrostomy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904779
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026