510(k) · Cleared
ClearedBard Balloon Dilation Kit with Trifunnel Gastrostomy Tube
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 Feb 13, 2007 as substantially equivalent to K915841 (C.R. Bard, Inc., 1993) after a 125-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it.
- Decided
- Feb 13, 2007
- Review
- 125 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915841 (1993). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK915841 Bard Gauderer Universal Percutaneous EndoscopicC.R. Bard, Inc. · 1993 · Recalled
- This deviceK063118 Bard Balloon Dilation Kit with Trifunnel Gastrostomy TubeC.R. Bard, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK092049 Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSainath Intellectual Properties, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK102572 Iyunni 3ID Suprapubic Cystostomy Tube KitSainath Intellectual Properties, LLC · 2010
- Descendant · cites it directly · 0 of its ownK100173 Iyunni 3ID Tri-Funnel Feeding Tube KitSainath Intellectual Properties, LLC · 2010
Most influential descendants
Showing 3 of 3 · See all- K092049Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSainath Intellectual Properties, LLC · 2009 · cites it directly2descendants
- K102572Iyunni 3ID Suprapubic Cystostomy Tube KitSainath Intellectual Properties, LLC · 2010 · 2 generations on0descendants
- K100173Iyunni 3ID Tri-Funnel Feeding Tube KitSainath Intellectual Properties, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915841 | Bard Gauderer Universal Percutaneous Endoscopic | C.R. Bard, Inc. | 1993 | 29 |
| 0 (this device) | K063118 | Bard Balloon Dilation Kit with Trifunnel Gastrostomy Tube | C.R. Bard, Inc. | 2007 | — |
| +1 | K092049 | Iyunni 3ID Tri-Funnel Gastrostomy Tube Kit | Sainath Intellectual Properties, LLC | 2009 | — |
| +2 | K102572 | Iyunni 3ID Suprapubic Cystostomy Tube Kit | Sainath Intellectual Properties, LLC | 2010 | — |
| +1 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 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 |
|---|---|---|---|
| * | K915841 | Bard Gauderer Universal Percutaneous EndoscopicSummary page 1…stinal Tube &Accessories CFR Reference: 21 CFR §876.5980, Class II Classification Panel: Gastroenterology/Urology Premarket Notification: K915841, clearance date 06/25/1993 5.4 Intended Use The "intended use" is the same for the subject and predicate kit. The kit… | 1993 |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- Of its descendants, K092049 (Sainath Intellectual Properties, LLC, 2009) has gone furthest, with 2 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. 2007, this device’s year, is highlighted.
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?
For initial percutaneous placement of a gastrostomy feeding and/or decompression device into a stoma created by tissue dilation.
Also for percutaneous replacement of a gastrostomy feeding and/or decompression device into an established stoma site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063118 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063118: Bard Balloon Dilation Kit with Trifunnel Gastrostomy Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063118
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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