510(k) · Cleared
ClearedWell Lead PVC Hydrophilic Urethral Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Medical Co., Ltd. · EZD Catheter, Straight
Cleared on Feb 24, 2014 as substantially equivalent to K062444 (Oasis Medikal Urunler Kimya Sanayi VE Tic A.S., 2007) after a 91-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- Feb 24, 2014
- Review
- 91 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910022 (1991). 9 ancestors in all, the oldest K896750 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 3 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 2 generations backK023254 SpeedicathColoplast Corp. · 2003
- 1 generation backK062444 HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters…Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. · 2007
- This deviceK133615 Well Lead PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK220722 PVC Hydrophilic Urethral CatheterWell Lead Medical Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK142563 Well Lead PVC Urethral CatheterWell Lead Medical Co., Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −3 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −2 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| −1 | K062444 | HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit | Oasis Medikal Urunler Kimya Sanayi VE Tic A.S. | 2007 | — |
| 0 (this device) | K133615 | Well Lead PVC Hydrophilic Urethral Catheter | Well Lead Medical Co., Ltd. | 2014 | — |
| +1 | K220722 | PVC Hydrophilic Urethral Catheter | Well Lead Medical Co., Ltd. | 2023 | — |
| +1 | K142563 | Well Lead PVC Urethral Catheter | Well Lead Medical Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2023 | 1 | 0 |
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? (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 |
|---|---|---|---|
| * | K062444 | HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and KitSummary page 2…ldren ages 2 years old to less than 12 years old, Sizes I 2Fr - 24Fr are for 12 years old and over. Predicate Device: K062444 - Hi-Slip Single Use Hydrophilic Urinary Catheter. Substanti… | 2007 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K220722 (Well Lead Medical Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K062444.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Well Lead PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization -CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133615: Well Lead PVC Hydrophilic Urethral Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133615
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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