510(k) · Cleared
Recalled · Class II · 2024Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jun 27, 2003 as substantially equivalent to K030855 (Boston Scientific Corp, 2003) after a 42-day review. Its family tree reaches back 2 generations to 2002. 3 later devices descend from it. It has been recalled 21 times.
- Decided
- Jun 27, 2003
- Review
- 42 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 21
- Predicates
- 1
Its longest line of descent runs back 2 generations to K014297 (2002). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK014297 Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile…Boston Scientific Corp · 2002
- 1 generation backK030855 Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit…Boston Scientific Corp · 2003 · Recalled
- This deviceK031538 Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety KitBoston Scientific Corp · 2003
- Descendant · cites it directly · 1 of its ownK061021 Entake Standard and Safety Peg SystemConmedcorp · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK182248 Aspire Venting TubeAspire Bariatrics, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK150679 EndoVive Initial Placement Standard PEG Kit with ENFit Connector…Boston Scientific Corp · 2015 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K061021Entake Standard and Safety Peg SystemConmedcorp · 2006 · cites it directly1descendant
- K182248Aspire Venting TubeAspire Bariatrics, Inc. · 2018 · 2 generations on0descendants
- K150679EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial…Boston Scientific Corp · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K014297 | Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button… | Boston Scientific Corp | 2002 | — |
| −1 | K030855 | Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety… | Boston Scientific Corp | 2003 | 2 |
| 0 (this device) | K031538 | Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit | Boston Scientific Corp | 2003 | — |
| +1 | K061021 | Entake Standard and Safety Peg System | Conmedcorp | 2006 | 28 |
| +2 | K182248 | Aspire Venting Tube | Aspire Bariatrics, Inc. | 2018 | — |
| +1 | K150679 | EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive… | Boston Scientific Corp | 2015 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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 KNT? 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 KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 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 |
|---|---|---|---|
| * | K030855 | Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety KitSummary page 1…Classified as a Class I1 Device PREDICATE DEVICES: EndoViveTMInitial Placement PEG Kit (K030855) EndoViveTMInitial Placement Direct PEJ Kit… | 2003 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2024 | Class II | Z-1516-2024 | Process design | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events… |
| Feb 20, 2024 | Class II | Z-1515-2024 | Process design | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events… |
| Feb 20, 2024 | Class II | Z-1517-2024 | Process design | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events… |
| May 5, 2009 | Not classified | Z-1631-2009 | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. |
| May 5, 2009 | Not classified | Z-1625-2009 | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. |
| May 5, 2009 | Not classified | Z-1632-2009 | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. |
| May 5, 2009 | Not classified | Z-1626-2009 | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. |
| May 5, 2009 | Not classified | Z-1630-2009 | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. |
| May 5, 2009 | Not classified | Z-1627-2009 | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. |
| May 5, 2009 | Not classified | Z-1629-2009 | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. |
| May 5, 2009 | Not classified | Z-1628-2009 | Process control | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. |
| Dec 30, 2008 | Not classified | Z-0912-2009 | Other | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. |
| Dec 30, 2008 | Not classified | Z-0913-2009 | Other | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. |
| Dec 30, 2008 | Not classified | Z-0914-2009 | Other | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. |
| Dec 30, 2008 | Not classified | Z-0911-2009 | Other | The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device. |
| Jun 2, 2005 | Not classified | Z-0963-05 | Other | Two blades may be heat staked onto the stiletto instead of the expected one blade. |
| Jun 2, 2005 | Not classified | Z-0966-05 | Other | Two blades may be heat staked onto the stiletto instead of the expected one blade. |
| Jun 2, 2005 | Not classified | Z-0968-05 | Other | Two blades may be heat staked onto the stiletto instead of the expected one blade. |
| Jun 2, 2005 | Not classified | Z-0965-05 | Other | Two blades may be heat staked onto the stiletto instead of the expected one blade. |
| Jun 2, 2005 | Not classified | Z-0964-05 | Other | Two blades may be heat staked onto the stiletto instead of the expected one blade. |
| Jun 2, 2005 | Not classified | Z-0967-05 | Other | Two blades may be heat staked onto the stiletto instead of the expected one blade. |
The 5 latest of 21 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 1 company; a new generation was cleared every 9 months on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K061021 (Conmedcorp, 2006) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K030855.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, 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 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
EndoVive Initial Placement PEG Kit is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. The EndoVive Initial Placement Direct PEJ Kit is indicated for nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated. The EndoVive Initial Placement PEG Safety Kit is indicated for…
Read the full statement (107 words)
EndoVive Initial Placement PEG Kit is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.
The EndoVive Initial Placement Direct PEJ Kit is indicated for nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated.
The EndoVive Initial Placement PEG Safety Kit is indicated for providing nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means. The safety components of the kit are designed to reduce the potential for inadvertent sharps injury to medical personnel during and after the procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031538: Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031538
Report an extraction error
Are you the manufacturer?
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