510(k) · Cleared
ClearedKendall Curity Suprapubic Catheter Tray, Kit, & Replacement Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Kendal Co. · KOB Catheter, Suprapubic (And Accessories)
Cleared on Apr 23, 1997 as substantially equivalent to K842899 (The Kendal Co., 1984) after a 37-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Apr 23, 1997
- Review
- 37 days
- Class
- Class II
- Product code
- KOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K842899 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK842899 Curity Suprapubic Drainage SystemThe Kendal Co. · 1984
- This deviceK970969 Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement SetThe Kendal Co. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842899 | Curity Suprapubic Drainage System | The Kendal Co. | 1984 | — |
| 0 (this device) | K970969 | Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement Set | The Kendal Co. | 1997 | — |
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? (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 |
|---|---|---|---|
| * | K842899 | Curity Suprapubic Drainage SystemSummary page 1…URITY Suprapubic Catheter Trays and Kits are substantially equivalent in intended use, design and function to the _ Kendall CURITY Suprapubic Drainage System, 510(k) No. K842899. 4. Description of Device The Kendall Suprapubic Catheter Trays and Kits are sterile, single use devices which are designed to… | 1984 |
What descends from it?
No later submission names this one as a predicate yet.
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 no recall.
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 Kendall CURITY Suprapubic Catheter Trays and kits are intended to provide urinary bladder drainage or irrigation by percutaneous placement of a suprapubic catheter. This is a useful method of controlling urinary bladder drainage postoperatively.
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/K970969 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970969: Kendall Curity Suprapubic Catheter Tray, Kit, & Replacement Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970969
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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