510(k) · Decided
Recalled · 2008Bard Gauderer Universal Percutaneous Endoscopic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Jun 25, 1993 after a 549-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled 29 times.
- Decided
- Jun 25, 1993
- Review
- 549 days
- Class
- Class II
- Product code
- KNT
- Recalls
- 29
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK915841 Bard Gauderer Universal Percutaneous EndoscopicC.R. Bard, Inc. · 1993
- Descendant · cites it directly · 3 of its ownK063118 Bard Balloon Dilation Kit with Trifunnel Gastrostomy TubeC.R. Bard, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK092049 Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSainath Intellectual Properties, LLC · 2009
- Descendant · 3 generations on · 0 of its ownK102572 Iyunni 3ID Suprapubic Cystostomy Tube KitSainath Intellectual Properties, LLC · 2010
- Descendant · 2 generations on · 0 of its ownK100173 Iyunni 3ID Tri-Funnel Feeding Tube KitSainath Intellectual Properties, LLC · 2010
Most influential descendants
Showing 4 of 4 · See all- K063118Bard Balloon Dilation Kit with Trifunnel Gastrostomy TubeC.R. Bard, Inc. · 2007 · cites it directly3descendants
- K092049Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSainath Intellectual Properties, LLC · 2009 · 2 generations on2descendants
- K102572Iyunni 3ID Suprapubic Cystostomy Tube KitSainath Intellectual Properties, LLC · 2010 · 3 generations on0descendants
- K100173Iyunni 3ID Tri-Funnel Feeding Tube KitSainath Intellectual Properties, LLC · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915841 | Bard Gauderer Universal Percutaneous Endoscopic | C.R. Bard, Inc. | 1993 | — |
| +1 | K063118 | Bard Balloon Dilation Kit with Trifunnel Gastrostomy Tube | C.R. Bard, Inc. | 2007 | — |
| +2 | K092049 | Iyunni 3ID Tri-Funnel Gastrostomy Tube Kit | Sainath Intellectual Properties, LLC | 2009 | — |
| +3 | K102572 | Iyunni 3ID Suprapubic Cystostomy Tube Kit | Sainath Intellectual Properties, LLC | 2010 | — |
| +2 | K100173 | Iyunni 3ID Tri-Funnel Feeding Tube Kit | Sainath Intellectual Properties, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063118 | Bard Balloon Dilation Kit with Trifunnel Gastrostomy Tube | 2007 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 4, 2008 | Not classified | Z-2187-2009 | Nonconforming Material/Component | The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating… |
| Dec 4, 2008 | Not classified | Z-2179-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2186-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2200-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2203-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2183-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2185-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2184-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2205-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2191-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2193-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2194-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2204-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2197-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2206-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2192-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2189-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2181-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2198-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2195-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2180-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2196-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2188-2009 | Nonconforming Material/Component | The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating… |
| Dec 4, 2008 | Not classified | Z-2201-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2207-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2199-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2190-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2182-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
| Dec 4, 2008 | Not classified | Z-2202-2009 | Nonconforming Material/Component | Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal… |
The 5 latest of 29 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K063118 (C.R. Bard, Inc., 2007) has gone furthest, with 3 descendants of its own.
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
2007high 16 (2014) · low 4 (2025)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
2007high 259 (2014) · low 99 (2016)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
2007high 82 (2008) · low 0 (2013)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
2007high 1,901 (2018) · low 300 (2007)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 | — |
https://510kreport.com/device/K915841 · printed Nov 5, 2026
Cite this page
510(k) Report. “K915841: Bard Gauderer Universal Percutaneous Endoscopic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K915841
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026