510(k) · Cleared
Recalled · Class II · 2015Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xeridiem (Formerly Mri) · PIF Gastrointestinal Tubes With Enteral Specific Connectors
Cleared on Jan 8, 2015 as substantially equivalent to K043114 (Kimberly-Clark Corp., 2004) and 1 other predicate after a 143-day review. Its family tree reaches back 1 generation to 1998. It has been recalled 104 times.
- Decided
- Jan 8, 2015
- Review
- 143 days
- Class
- Class II
- Product code
- PIF
- Recalls
- 104
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971434 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK971434 A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding DeviceApplied Medical Technologies · 1998
- This deviceK142297 Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension…Xeridiem (Formerly Mri) · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971434 | A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding Device | Applied Medical Technologies | 1998 | — |
| 0 (this device) | K142297 | Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo… | Xeridiem (Formerly Mri) | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K043114 | Kimberly-Clark Mic-Key Low Profile Gastrostomy TubeSummary page 4…FR 876.5980, Product Code KNT] Classification Panel: Gastroenterology/Urology Class: Class II 510(k) Number: K043114 Secondary Predicate Device Information Trade Name: AMT Mini ONE® Balloon Button Low Profile Gastrostomy D… | 2004 |
| * | K971434 | A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding DeviceSummary page 4…FR 876.5980, Product Code KNT] Classification Panel: Gastroenterology/Urology Class: Class II 510(k) Number: K971434 Xeridiem 01/06/15 Page 5-2 === Page 5… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 23, 2015 | Class II | Z-0924-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0947-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0933-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0981-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0950-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0917-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0938-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0963-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0954-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0974-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0979-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0955-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0912-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0916-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0958-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0930-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0929-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0945-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0940-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0952-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0942-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0949-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0941-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0951-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0975-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0968-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0962-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0978-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0980-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0956-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0915-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0914-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0922-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0935-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0926-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0928-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0932-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0961-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0944-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0931-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0946-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0920-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0948-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0939-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0973-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0919-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0927-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0943-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0977-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
| Dec 23, 2015 | Class II | Z-0964-2016 | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric… |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K043114.
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. 2015, this device’s year, is highlighted.
FDA decisions per year · PIF
2in 2025
2007high 9 (2015) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · PIF
242in 2023
2007high 267 (2016) · low 119 (2014)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PIF
1in 2024
2007high 106 (2015) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PIF
83in 2025
2007high 110 (2024) · low 0 (2007)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 EndoVive™ 3S Low Profile Balloon is indicated for use in adult and pediatric patients who require long term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
The EndoVive™ 3S Extension Set is indicated for the delivery of nutrition, hydration and/or medication into the stomach through a low profile balloon and also provides a mechanism for gastric decompression.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142297 · printed Nov 4, 2026
Cite this page
510(k) Report. “K142297: Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K142297
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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