510(k) · Cleared
ClearedWell Lead Hydrophilic Silicone Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Medical Co., Ltd. · EZL Catheter, Retention Type, Balloon
Cleared on Dec 15, 2014 as substantially equivalent to K984084 (Bard Medical Div., 1999) and 2 other predicates after a 272-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Dec 15, 2014
- Review
- 272 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K984084 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK984084 Bardex Lubri-Sil Foley CatheterBard Medical Div. · 1999 · Recalled
- 1 generation backK070508 Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc. · 2007 · Recalled
- This deviceK140667 Well Lead Hydrophilic Silicone Foley CatheterWell Lead Medical Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K984084 | Bardex Lubri-Sil Foley Catheter | Bard Medical Div. | 1999 | 1 |
| −1 | K070508 | Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FR | C.R. Bard, Inc. | 2007 | 1 |
| 0 (this device) | K140667 | Well Lead Hydrophilic Silicone Foley Catheter | Well Lead Medical Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 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 EZL? 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 EZL device
- #1 K260756 TraumaGuard Intra-Abdominal Pressure-Sensing…score 13.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K984084 | Bardex Lubri-Sil Foley CatheterSummary page 4…the bladder to drain urine. The Three-way Catheter provides a lumen that is used for bladder irrigation. Predicate Device(s): K984084- Bardex® Lubri-SilTM Foley Catheter K002868-Bardex® Lubri-SilTM 3-way Foley Catheter… | 1999 |
| * | K002868 | Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley Catheter; Bard…Summary page 4…provides a lumen that is used for bladder irrigation. Predicate Device(s): K984084- Bardex® Lubri-SilTM Foley Catheter K002868-Bardex® Lubri-SilTM 3-way Foley Catheter K070508-Bardex® Lubri-Sil® All-Silicone Lubricious Coated… | 2000 |
| * | K070508 | Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRSummary page 4…(s): K984084- Bardex® Lubri-SilTM Foley Catheter K002868-Bardex® Lubri-SilTM 3-way Foley Catheter K070508-Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6Fr Traditional 510(k) for Well… | 2007 |
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 3 other devices also cite its predicate K984084.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · EZL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZL
123in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZL
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · EZL
1,381in 2025
MAUDE reports naming product code EZL, 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 | 7 | 186 | 0 | 8 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 4 | 114 | 0 | 6 |
| 2010 | 1 | — | 0 | 27 |
| 2011 | 2 | — | 0 | 79 |
| 2012 | 0 | — | 0 | 65 |
| 2013 | 3 | 151 | 0 | 99 |
| 2014 | 2 | — | 0 | 229 |
| 2015 | 3 | 132 | 0 | 303 |
| 2016 | 1 | — | 0 | 326 |
| 2017 | 2 | — | 0 | 571 |
| 2018 | 9 | 177 | 0 | 677 |
| 2019 | 3 | 266 | 1 | 671 |
| 2020 | 4 | 137 | 0 | 712 |
| 2021 | 2 | — | 0 | 702 |
| 2022 | 2 | — | 0 | 884 |
| 2023 | 3 | 282 | 2 (2) | 772 |
| 2024 | 5 | 123 | 2 | 1,029 |
| 2025 | 1 | — | 0 | 1,381 |
| 2026 | 4 | 170 | 2 | — |
What is it indicated for?
The Well Lead Hydrophilic Silicone Foley Catheter is intended for use for bladder management including urine drainage, collection and measurement. The Catheter is passed through the urethra during urinary catheterization and into the bladder to drain urine. The Three-way Catheter provides a lumen that is used for bladder irrigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140667: Well Lead Hydrophilic Silicone Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140667
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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