510(k) · Cleared
ClearedCatheter Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
World Metals, Inc. · KNY Accessories, Catheter, G-U
Cleared on Feb 28, 2003 after a 119-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 28, 2003
- Review
- 119 days
- Class
- Class II
- Product code
- KNY
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
Top candidate predicates for a new KNY device
- #1 K260919 Transurethral Catheter Safety Valve (TUCSV)…score 11.8 · 1 generation · 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 |
|---|---|---|---|
| * | — | simple urinary catheter plug Named without a submission number |
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.
How does its category compare?
All KNY devicesKNY Accessories, Catheter, G-U: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Quick Disconnect Plug is intended to stop the flow of urine from the urinary catheter to the drainage bag. It is intended for use on a short term basis of no longer than two weeks (14 days) duration. The daily disconnection schedule should not exceed two hours. This device is available sterile for one-time use by physician's prescription.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023690: Catheter Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023690
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026