510(k) · Decided
DecidedEntuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xeridiem Medical Devices, A Spectrum Plastics Group Company · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Oct 18, 2018 as substantially equivalent to K130674 (Xeridiem Medical Devices, 2014) after a 213-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- Oct 18, 2018
- Review
- 213 days
- Class
- Class II
- Product code
- PIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K901501 (1990). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK901501 Corpak Gastrostomy TubeCorpak Co. · 1990
- 3 generations backK962375 Microvasive Balloon Gastrostomy Tube KitBoston Scientific Corp · 1996
- 2 generations backK083685 Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283…Mri Manufacturing and Research, Inc. · 2009
- 1 generation backK130674 Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeXeridiem Medical Devices · 2014
- This deviceK180708 Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2018
- Descendant · cites it directly · 0 of its ownK232046 Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2023
Most influential descendants
Showing 1 of 1 · See all- K232046Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT…Xeridiem Medical Devices, A Spectrum Plastics Group Company · 2023 · cites it directly0descendants
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 | K083685 | Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285 | Mri Manufacturing and Research, Inc. | 2009 | — |
| −1 | K130674 | Entuit Thrive LP Balloon Retention Gastrostomy Feeding Tube | Xeridiem Medical Devices | 2014 | — |
| 0 (this device) | K180708 | Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP… | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2018 | — |
| +1 | K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with… | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K130674 | Entuit Thrive LP Balloon Retention Gastrostomy Feeding TubeSummary page 8…Classification Name: Gastrointestinal tube and accessories (21 CFR 876.5980, Product Codes KNT) 510(k) Number: K130674 Xeridiem Medical Devices 10/16/18 Page 5-2… | 2014 |
| † | K142297 | Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S… | 2015 |
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 |
|---|---|---|---|
| K232046 | Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT… | 2023 | 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 28 years and passes through 5 companies; a new generation was cleared every 6.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K232046 (Xeridiem Medical Devices, A Spectrum Plastics Group Company, 2023) 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. 2018, 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 feeding tube 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. The Entuit LP Patient Care Kit is indicated for use in adult and pediatric patients that require enteral feeding, medication administration or decompression through an Entuit LP Gastrostomy BR Balloon…
Read the full statement (172 words)
The feeding tube 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.
The Entuit LP Patient Care Kit is indicated for use in adult and pediatric patients that require enteral feeding, medication administration or decompression through an Entuit LP Gastrostomy BR Balloon Retention Feeding Tube.
The Entuit LP Patient Care Kit with ENFit Connection is indicated for use in adult and pediatric patients that require enteral feeding, medication administration or decompression through an Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube.
The feeding tube 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.
The PromaX LP Patient Care Kit with ENFit is indicated for use in adult and pediatric patients that require enteral feeding, medication administration, or decompression through a PromaX Low Profile Gastrostomy Feeding Tube.
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/K180708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180708: Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180708
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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