510(k) · Cleared
ClearedRusch Suprapubic Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch, Inc. · KOB Catheter, Suprapubic (And Accessories)
Cleared on Feb 7, 1997 after a 35-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Feb 7, 1997
- Review
- 35 days
- Class
- Class II
- Product code
- KOB
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK970021 Rusch Suprapubic TrayRusch, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK132890 Suprapubic Catheter and Introducer SetMediplus, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK182066 O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK102572 Iyunni 3ID Suprapubic Cystostomy Tube KitSainath Intellectual Properties, LLC · 2010
Most influential descendants
Showing 3 of 3 · See all- K132890Suprapubic Catheter and Introducer SetMediplus, Ltd. · 2014 · cites it directly1descendant
- K182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook Incorporated · 2018 · 2 generations on0descendants
- K102572Iyunni 3ID Suprapubic Cystostomy 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 |
|---|---|---|---|---|---|
| 0 (this device) | K970021 | Rusch Suprapubic Tray | Rusch, Inc. | 1997 | — |
| +1 | K132890 | Suprapubic Catheter and Introducer Set | Mediplus, Ltd. | 2014 | — |
| +2 | K182066 | O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set | Cook Incorporated | 2018 | — |
| +1 | K102572 | Iyunni 3ID Suprapubic Cystostomy Tube Kit | Sainath Intellectual Properties, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 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 KOB? 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 KOB device
- #1 K240514 AMT Low-Profile Suprapubic Catheter & Drainage…score 8.9 · 3 generations · no Class I recall
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | Rusch SupraFoley Suprapubic Introducer and Foley Catheter Named without a submission number | |
| * | — | Rusch Simplastic Suprapubic Catheter Named without a submission number | |
| * | — | Microvasive Percutaneous Suprapubic Balloon Catheter Set Named without a submission number | |
| * | — | Cook Stamey Percutaneous Catheter Set Named without a submission number | |
| * | — | Rusch Suprapubic Catheters Named without a submission number |
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?
- Of its descendants, K132890 (Mediplus, Ltd., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KOB devicesKOB Catheter, Suprapubic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KOB
Too few KOB 510(k)s in any year since 2007 to give a median.
Recalls per year · KOB
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOB
1in 2025
MAUDE reports naming product code KOB, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 0 | 18 |
| 2019 | 1 | — | 2 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The kit is used for percutaneous bladder drainage and to drain fiuids to and from the urinary tract.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970021: Rusch Suprapubic Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970021
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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