510(k) · Cleared
Recalled · Class II · 2026Corpak Percutaneous Endoscopic Gastrostomy Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corpak Co. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Sep 21, 1988 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 14 times.
- Decided
- Sep 21, 1988
- Review
- 72 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 14
- 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 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?
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 |
|---|---|---|---|---|
| Apr 30, 2026 | Class II | Z-2340-2026 | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. |
| Apr 30, 2026 | Class II | Z-2335-2026 | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. |
| Apr 30, 2026 | Class II | Z-2334-2026 | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. |
| Apr 30, 2026 | Class II | Z-2338-2026 | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. |
| Apr 30, 2026 | Class II | Z-2333-2026 | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. |
| Apr 30, 2026 | Class II | Z-2337-2026 | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. |
| Apr 30, 2026 | Class II | Z-2336-2026 | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. |
| Apr 30, 2026 | Class II | Z-2339-2026 | Material/Component Contamination | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. |
| Mar 16, 2020 | Class II | Z-1822-2020 | Under Investigation by firm | The CORFLO PEG tube may become blocked at the center of the adapter (occluded) potentially causing a procedure to delayed or aborted. |
| Oct 8, 2019 | Class II | Z-0370-2020 | Under Investigation by firm | The connector piece to the PEG tube does not pass over the guidewire. |
| Oct 8, 2019 | Class II | Z-0371-2020 | Under Investigation by firm | The connector piece to the PEG tube does not pass over the guidewire. |
| Feb 3, 2017 | Class II | Z-2162-2017 | Device Design | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress. |
| Feb 3, 2017 | Class II | Z-2163-2017 | Device Design | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress. |
| Feb 3, 2017 | Class II | Z-2161-2017 | Device Design | Firm is initiating voluntary correction of CORFLO PEG with ENFit. Barb connector (stem) of the adapter may break unexpectedly when exposed to stress. |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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 | — |
https://510kreport.com/device/K882867 · printed Nov 5, 2026
Cite this page
510(k) Report. “K882867: Corpak Percutaneous Endoscopic Gastrostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K882867
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026