510(k) · Decided
DecidedIyunni 3ID Tri-Funnel Gastrostomy Tube Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sainath Intellectual Properties, LLC · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Oct 9, 2009 as substantially equivalent to K063118 (C.R. Bard, Inc., 2007) and 1 other predicate after a 94-day review. Its family tree reaches back 2 generations to 1993. 1 of the 9 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Oct 9, 2009
- Review
- 94 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K915841 (1993). 6 ancestors in all, the oldest K852363 (1985). 2 later devices descend from it, 2 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK915841 Bard Gauderer Universal Percutaneous EndoscopicC.R. Bard, Inc. · 1993 · Recalled
- 1 generation backK063118 Bard Balloon Dilation Kit with Trifunnel Gastrostomy TubeC.R. Bard, Inc. · 2007
- This deviceK092049 Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSainath Intellectual Properties, LLC · 2009
- Descendant · cites it directly · 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
Class I recalls in this family
- K921370 Mic Gastro-Enterostomy Tube Modification2 generations back · 1994
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915841 | Bard Gauderer Universal Percutaneous Endoscopic | C.R. Bard, Inc. | 1993 | 29 |
| −1 | K063118 | Bard Balloon Dilation Kit with Trifunnel Gastrostomy Tube | C.R. Bard, Inc. | 2007 | — |
| 0 (this device) | K092049 | Iyunni 3ID Tri-Funnel Gastrostomy Tube Kit | Sainath Intellectual Properties, LLC | 2009 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1994 | 2 | 1 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has a Class I recall. 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? (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.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K921370Mic Gastro-Enterostomy Tube ModificationMedical Innovations Corp. · 1994 · 2 generations back · ◆ in the 1994 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 13.6 years on median.
- 2 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K102572 (Sainath Intellectual Properties, LLC, 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K063118.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The IYUNNI TM 31D Tri-Funnel Gastrostomy Tube Kit is indicated for use in percutaneous placement of a gastrostomy tube for feeding and/or medication using a Percutaneous Endoscopic Gastrostomy procedure. The gastrostomy tube may also be used for gastric decompression.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092049: Iyunni 3ID Tri-Funnel Gastrostomy Tube Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092049
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