510(k) · Cleared
ClearedIyunni 3ID Suprapubic Cystostomy 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 Dec 27, 2010 as substantially equivalent to K092049 (Sainath Intellectual Properties, LLC, 2009) and 2 other predicates after a 110-day review. Its family tree reaches back 3 generations to 1993. 1 of the 10 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 27, 2010
- Review
- 110 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K915841 (1993). 9 ancestors in all, the oldest K852363 (1985). No later device cites it as a predicate yet. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK915841 Bard Gauderer Universal Percutaneous EndoscopicC.R. Bard, Inc. · 1993 · Recalled
- 2 generations backK063118 Bard Balloon Dilation Kit with Trifunnel Gastrostomy TubeC.R. Bard, Inc. · 2007
- 1 generation backK092049 Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSainath Intellectual Properties, LLC · 2009
- This deviceK102572 Iyunni 3ID Suprapubic Cystostomy Tube KitSainath Intellectual Properties, LLC · 2010
Class I recalls in this family
- K921370 Mic Gastro-Enterostomy Tube Modification3 generations back · 1994
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915841 | Bard Gauderer Universal Percutaneous Endoscopic | C.R. Bard, Inc. | 1993 | 29 |
| −2 | 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 | — |
| 0 (this device) | K102572 | Iyunni 3ID Suprapubic Cystostomy 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 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2008 | 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.
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? (3)
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 |
|---|---|---|---|
| * | K092049 | Iyunni 3ID Tri-Funnel Gastrostomy Tube KitSummary page 1…Classification: Class 11 3. Predicate Device: IYUNNP' m 31D Tni-Funnel Gastrostomy Tube Kit, K092049 Rfisch Suprapubic Catheter Tray/Kit, K(970021 Rbsch SupraflexTM Suprapubi… | 2009 |
| * | K970021 | Rusch Suprapubic TraySummary page 1…Predicate Device: IYUNNP' m 31D Tni-Funnel Gastrostomy Tube Kit, K092049 Rfisch Suprapubic Catheter Tray/Kit, K(970021 Rbsch SupraflexTM Suprapubic Catheter, K952187 4. Device Description:… | 1997 |
| * | K952187 | Rusch Supraflex Suprapubic Cystostomy Catheter Kit, SterileSummary page 1…astrostomy Tube Kit, K092049 Rfisch Suprapubic Catheter Tray/Kit, K(970021 Rbsch SupraflexTM Suprapubic Catheter, K952187 4. Device Description: The kit consists of two major components: IYUNNITM Suprapubic… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 3 generations back · ◆ in the 1994 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K092049.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 IYUNN T m 31D Supvapubic Cystostomy Kit is indicated for use in suprapubic bladder catherization and drainage of fluids to and from the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102572 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102572: Iyunni 3ID Suprapubic Cystostomy Tube Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102572
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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