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. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Jan 20, 2022 as substantially equivalent to K183336 (Wilson-Cook Medical, Inc., 2019) after a 100-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Jan 20, 2022
- Review
- 100 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K920703 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK920703 Gastrointestinal Feeding TubeWilson-Cook Medical, Inc. · 1993 · Recalled
- 1 generation backK183336 Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2019
- This deviceK213356 Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK254170 Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone, Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K254170Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920703 | Gastrointestinal Feeding Tube | Wilson-Cook Medical, Inc. | 1993 | 1 |
| −1 | K183336 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2019 | — |
| 0 (this device) | K213356 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2022 | — |
| +1 | K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Degania Silicone, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 PIF? 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 PIF device
- #1 K253715 Edi Catheter ENFit 6Fr/48 cm (6893166); Edi…score 15.5 · 13 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 |
|---|---|---|---|
| * | K183336 | Entuit PEG, Entuit PEGJSummary page 5…Entuit PEGJ Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tubes and accessories Regulatory Class: II Product Code: KNT, PIF Predicate Device: K183336 Entuit PEG / Entuit PEGJ cleared to market May 29, 2019 Device Description: The Entuit PEG (subject device) includes a silicone… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | 2026 | 0 |
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?
- The line of descent spans 29 years and passes through 1 company; a new generation was cleared every 25.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K254170 (Degania Silicone, Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PIF devicesPIF Gastrointestinal Tubes With Enteral Specific Connectors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PIF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PIF
242in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PIF
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIF
83in 2025
MAUDE reports naming product code PIF, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 119 | 0 | 0 |
| 2015 | 9 | 143 | 106 | 12 |
| 2016 | 3 | 267 | 0 | 45 |
| 2017 | 5 | 174 | 0 | 17 |
| 2018 | 2 | — | 0 | 17 |
| 2019 | 7 | 135 | 0 | 28 |
| 2020 | 4 | 165 | 0 | 70 |
| 2021 | 4 | 242 | 0 | 89 |
| 2022 | 4 | 167 | 0 | 77 |
| 2023 | 4 | 242 | 0 | 96 |
| 2024 | 2 | — | 1 | 110 |
| 2025 | 2 | — | 0 | 83 |
| 2026 | 3 | 239 | 0 | — |
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 PEGIJ 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213356: Entuit PEG, Entuit PEGJ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213356
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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