510(k) · Cleared
ClearedTransurethral Catheter Safety Valve (TUCSV) (80050)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Class Medical, Ltd. · KNY Accessories, Catheter, G-U
Cleared on Aug 5, 2026 as substantially equivalent to K182635 (Safe Medical Design, 2019) after a 139-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Aug 5, 2026
- Review
- 139 days
- Class
- Class II
- Product code
- KNY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K182635 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backK182635 Signal CatheterSafe Medical Design · 2019
- This deviceK260919 Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K182635 | Signal Catheter | Safe Medical Design | 2019 | — |
| 0 (this device) | K260919 | Transurethral Catheter Safety Valve (TUCSV) (80050) | Class Medical, Ltd. | 2026 | — |
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 KNY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K182635 | Signal CatheterSummary page 5…Class II Classification regulation 21 CFR 876.5130 Product Codes: KNY F. Predicate Device Signal Catheter K182635. The predicate device has not been subject to a design-related recall. G. Device Description The TUCSV Device is a sterile, sing… | 2019 |
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 KNY devicesKNY Accessories, Catheter, G-U: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · KNY
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KNY
103in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNY
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNY
3in 2025
MAUDE reports naming product code KNY, 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 | 15 |
| 2008 | 0 | — | 0 | 19 |
| 2009 | 1 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 1 | 6 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 3 | 103 | 0 | 7 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 1 | — | 0 | 21 |
| 2018 | 1 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 36 |
| 2021 | 0 | — | 0 | 17 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 1 | 5 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The TUC Safety Valve is indicated for single use during inflation of a Foley catheter retaining balloon in adult patients. The TUCSV alerts the user of premature inflation of the balloon within the urethra and alleviates the pressure, to aid in the prevention of incorrect balloon placement.
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/K260919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260919: Transurethral Catheter Safety Valve (TUCSV) (80050).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260919
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026