510(k) · Cleared
Recalled · 2011Uri-Drain Combo Kit for Male Incontinenc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chesebrough-Pond'S U.S.A. Co. · KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Cleared on Oct 18, 1977 after a 168-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 3 times.
- Decided
- Oct 18, 1977
- Review
- 168 days
- Class
- Class II
- Product code
- KNX
- Recalls
- 3
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KNX? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 29, 2011 | Not classified | Z-2393-2011 | Other | A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination |
| Apr 29, 2011 | Not classified | Z-2394-2011 | Other | A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination |
| Apr 29, 2011 | Not classified | Z-2392-2011 | Other | A component of the Uri-Drain device recalled the Skin-Prep (manufactured by H&P Industries-Triad) a protective wipe due to bacterial contamination |
No ancestor or descendant has a Class I recall.
How does its category compare?
All KNX devicesKNX Collector, Urine, (And Accessories) For Indwelling Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNX
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · KNX
Too few KNX 510(k)s in any year since 2007 to give a median.
Recalls per year · KNX
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNX
196in 2025
MAUDE reports naming product code KNX, 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 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 1 | — | 3 | 7 |
| 2012 | 0 | — | 0 | 16 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 15 |
| 2015 | 0 | — | 0 | 21 |
| 2016 | 0 | — | 1 | 82 |
| 2017 | 0 | — | 0 | 154 |
| 2018 | 0 | — | 0 | 190 |
| 2019 | 0 | — | 0 | 235 |
| 2020 | 0 | — | 0 | 215 |
| 2021 | 0 | — | 0 | 209 |
| 2022 | 0 | — | 0 | 167 |
| 2023 | 0 | — | 1 (1) | 178 |
| 2024 | 0 | — | 0 | 162 |
| 2025 | 0 | — | 0 | 196 |
| 2026 | 0 | — | 2 | — |
https://510kreport.com/device/K770789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K770789: Uri-Drain Combo Kit for Male Incontinenc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K770789
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026