510(k) · Cleared
ClearedBi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xeridiem Medical Devices · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Jun 6, 2017 as substantially equivalent to K142075 (Xeridiem (Formerly Mri), 2015) and 1 other predicate after a 29-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Jun 6, 2017
- Review
- 29 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K901501 (1990). 8 ancestors in all, the oldest K885339 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK901501 Corpak Gastrostomy TubeCorpak Co. · 1990
- 3 generations backK962375 Microvasive Balloon Gastrostomy Tube KitBoston Scientific Corp · 1996
- 2 generations backK083684 Endo Vive Standard Replacement Gastrostomy Tube, Model 82XXManufacturing & Research, Inc. · 2009
- 1 generation backK130611 Entuit Thrive Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2013
- This deviceK171347 Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit…Xeridiem Medical Devices · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901501 | Corpak Gastrostomy Tube | Corpak Co. | 1990 | — |
| −3 | K962375 | Microvasive Balloon Gastrostomy Tube Kit | Boston Scientific Corp | 1996 | — |
| −2 | K083684 | Endo Vive Standard Replacement Gastrostomy Tube, Model 82XX | Manufacturing & Research, Inc. | 2009 | — |
| −1 | K130611 | Entuit Thrive Balloon Retention Gastrostomy Feeding Tube | Xeridiem Medical Devices | 2013 | — |
| 0 (this device) | K171347 | Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection… | Xeridiem Medical Devices | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K142075 | BI-Funnel Gastrostomy Feeding Tube, Tri-Funnel Gastrostomy Feeding TubeSummary page 6…ies (21 CFR 876.5980, Product Code PIF) Classification Panel: Gastroenterology/Urology 510(k) Number: K142075/A001 5.3.2 Bundled Device 2 Trade Name: EntuitTM Thrive Balloon Retention Gastrostomy… | 2015 |
| * | K130611 | Entuit Thrive Balloon Retention Gastrostomy Feeding TubeSummary page 6…ies (21 CFR 876.5980, Product Code KNT) Classification Panel: Gastroenterology/Urology 510(k) Number: K130611/A001 5.4 Device Description 5.4.1 Bi-Funnel Gastrostomy Feeding Tube with ENFit® connector and Tri-Funnel Gastrostomy… | 2013 |
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 27 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- None of the 8 ancestors has a recall.
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. 2017, 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 Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector are indicated for placement in adult populations that require enteral feeding, medication administration or gastric decompression through an established gastrointestinal stoma tract.
The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration or decompression through an established gastrointestinal stoma tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171347: Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171347
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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