510(k) · Decided
DecidedEntuit PEG, Entuit PEGJ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on May 29, 2019 as substantially equivalent to K920703 (Wilson-Cook Medical, Inc., 1993) after a 177-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- May 29, 2019
- Review
- 177 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920703 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK920703 Gastrointestinal Feeding TubeWilson-Cook Medical, Inc. · 1993 · Recalled
- This deviceK183336 Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK213356 Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK254170 Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone, Ltd. · 2026
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 |
|---|---|---|---|---|---|
| −1 | K920703 | Gastrointestinal Feeding Tube | Wilson-Cook Medical, Inc. | 1993 | 1 |
| 0 (this device) | K183336 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2019 | — |
| +1 | K213356 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2022 | — |
| +2 | K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Degania Silicone, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K920703 | Gastrointestinal Feeding TubeSummary page 4…Number: 21 CFR 876.5980 Product Code: KNT, PIF Device Class: Class II Review Panel: Gastroenterology/Urology Predicate Device K920703 Gastrointestinal Feeding Tube (PEG 24 Fr/ PEGJ 12 Fr) Device Description The Entuit PEG includes a silicone enteral feeding tub… | 1993 |
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 |
|---|---|---|---|
| K213356 | Entuit PEG, Entuit PEGJ | 2022 | 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?
- Its one ancestor has a recall.
- Of its descendants, K213356 (Wilson-Cook Medical, Inc., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Entuit PEG is intended for percutaneous endoscopic gastrostomy placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.
The Entuit PEGJ is intended for percutaneous endoscopic placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183336 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183336: Entuit PEG, Entuit PEGJ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183336
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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