510(k) · Cleared
ClearedMentor Self-Cath Hydrogel Intermittent Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Corp. · EZD Catheter, Straight
Cleared on Jun 3, 2005 as substantially equivalent to K003873 (Mentor Corp., 2001) after a 151-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Jun 3, 2005
- Review
- 151 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003873 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003873 Mentor Self-Cath Closed SystemMentor Corp. · 2001
- This deviceK050008 Mentor Self-Cath Hydrogel Intermittent CatheterMentor Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003873 | Mentor Self-Cath Closed System | Mentor Corp. | 2001 | — |
| 0 (this device) | K050008 | Mentor Self-Cath Hydrogel Intermittent Catheter | Mentor Corp. | 2005 | — |
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 EZD? 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 EZD device
- #1 K241210 Luja Coudescore 16.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K003874 | FDA’s K003874 is CBC-4K Hematology Control Our reading of the summary gave K003874, FDA’s number for CBC-4K Hematology Control (R&D Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Mentor Self-Cath Plus Catheter”. Kept off the family tree. Summary page 2…CHG is substantially equivalent in form and function to Mentor's Self-Cath Plus Catheter and the Self- Cath Closed System, which were cleared under 510(k)s K003874 and K003873, respectively. Indications for Use The Mentor Self-Cath® HydroGel TM Intermittent Urethral Urinary Ca… | 2001 |
| * | K003873 | Mentor Self-Cath Closed SystemSummary page 2…antially equivalent in form and function to Mentor's Self-Cath Plus Catheter and the Self- Cath Closed System, which were cleared under 510(k)s K003874 and K003873, respectively. Indications for Use The Mentor Self-Cath® HydroGel TM Intermittent Urethral Urinary Catheter is… | 2001 |
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.
- 5 other devices also cite its predicate K003873.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZD
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EZD
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZD
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZD
288in 2025
MAUDE reports naming product code EZD, 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 | 4 | 121 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 4 | 116 | 1 | 4 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 4 | 110 | 0 | 18 |
| 2014 | 5 | 91 | 1 | 17 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 3 | 83 | 0 | 21 |
| 2017 | 2 | — | 0 | 120 |
| 2018 | 3 | 122 | 0 | 390 |
| 2019 | 0 | — | 0 | 466 |
| 2020 | 1 | — | 0 | 563 |
| 2021 | 0 | — | 0 | 994 |
| 2022 | 10 | 288 | 0 | 487 |
| 2023 | 6 | 214 | 0 | 553 |
| 2024 | 5 | 147 | 0 | 116 |
| 2025 | 6 | 130 | 0 | 288 |
| 2026 | 11 | 146 | 0 | — |
What is it indicated for?
The Mentor Self-Cath® HydroGel TM Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050008: Mentor Self-Cath Hydrogel Intermittent Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050008
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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