510(k) · Cleared
ClearedPercutaneous Endoscopic Gastrostomy (PEG) Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Degania Silicone, Ltd. · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Mar 20, 2026 as substantially equivalent to K213356 (Wilson-Cook Medical, Inc., 2022) after an 87-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Mar 20, 2026
- Review
- 87 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K920703 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK920703 Gastrointestinal Feeding TubeWilson-Cook Medical, Inc. · 1993 · Recalled
- 2 generations backK183336 Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2019
- 1 generation backK213356 Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2022
- This deviceK254170 Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920703 | Gastrointestinal Feeding Tube | Wilson-Cook Medical, Inc. | 1993 | 1 |
| −2 | K183336 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2019 | — |
| −1 | K213356 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | 2022 | — |
| 0 (this device) | K254170 | Percutaneous Endoscopic Gastrostomy (PEG) Kit | Degania Silicone, Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K213356 | Entuit PEG, Entuit PEGJSummary page 5…5980 Product Code(s) PIF, KNT | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K213356 Entuit PEG PIF, KNT Device Description Summary 21 CFR 807.92(a)(4) The Degania Silicone Percutaneous Endoscopic Gastrostomy (PEG… | 2022 |
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.
What does this lineage say?
- The line of descent spans 33 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
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. 2026, 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 PEG Catheter Kit 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.
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/K254170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254170: Percutaneous Endoscopic Gastrostomy (PEG) Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254170
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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