510(k) · Cleared
ClearedWell Lead Silicone and Latex Foley Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Medical Instruments · EZL Catheter, Retention Type, Balloon
Cleared on Oct 8, 2008 as substantially equivalent to K981612 (Rochester Medical Corp., 1998) and 1 other predicate after a 13-day review. Its family tree reaches back 2 generations to 1990. 10 later devices descend from it.
- Decided
- Oct 8, 2008
- Review
- 13 days
- Class
- Class II
- Product code
- EZL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K896053 (1990). 3 ancestors in all. 10 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK896053 All Silicone Foley CatheterRochester Medical Corp. · 1990
- 1 generation backK981612 All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley…Rochester Medical Corp. · 1998
- This deviceK082815 Well Lead Silicone and Latex Foley CathetersWell Lead Medical Instruments · 2008
- Descendant · cites it directly · 1 of its ownK233094 Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK142635 Medline Silicone Foley CatheterMedline Industries, Inc. · 2015 · Recalled
- Descendant · cites it directly · 1 of its ownK091516 Well Lead Silicone Catheter with Temperature SensorWell Lead Medical Co., Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK091767 3 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK243011 Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K233094Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd. · 2024 · cites it directly1descendant
- K142635Medline Silicone Foley CatheterMedline Industries, Inc. · 2015 · cites it directly1descendant
- K091516Well Lead Silicone Catheter with Temperature SensorWell Lead Medical Co., Ltd. · 2009 · cites it directly1descendant
- K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009 · cites it directly1descendant
- K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896053 | All Silicone Foley Catheter | Rochester Medical Corp. | 1990 | — |
| −1 | K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter… | Rochester Medical Corp. | 1998 | — |
| 0 (this device) | K082815 | Well Lead Silicone and Latex Foley Catheters | Well Lead Medical Instruments | 2008 | — |
| +1 | K233094 | Wellead® Latex Foley Catheter | Well Lead Medical (Hainan) Co., Ltd. | 2024 | — |
| +1 | K142635 | Medline Silicone Foley Catheter | Medline Industries, Inc. | 2015 | 1 |
| +1 | K091516 | Well Lead Silicone Catheter with Temperature Sensor | Well Lead Medical Co., Ltd. | 2009 | — |
| +1 | K091767 | 3 Way Silicone Foley Balloon Catheter | Cook Urological, Inc. | 2009 | — |
| +2 | K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter) | Guangdong Ecan Medical Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way…Summary page 2…X08-2-9113~' Predicate Device: Silicone - K981612 - Rochester Medical all Silicone Foley Catheter Latex - K040658 - Bard I.C Substantial Equivalence: Well Lead Medical Instrumen… | 1998 |
| * | K040658 | Bardex I.C. Latex Foley CatheterSummary page 2…X08-2-9113~' Predicate Device: Silicone - K981612 - Rochester Medical all Silicone Foley Catheter Latex - K040658 - Bard I.C Substantial Equivalence: Well Lead Medical Instruments claims the proposed devices to be substantially equivalent to… | 2004 |
What descends from it? (10)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233094 | Wellead® Latex Foley Catheter | 2024 | 1 |
| K142635 | Medline Silicone Foley Catheter | 2015 | 1 |
| K091516 | Well Lead Silicone Catheter with Temperature Sensor | 2009 | 1 |
| K091767 | 3 Way Silicone Foley Balloon Catheter | 2009 | 1 |
| K173657 | Radiance (TM) Clear Sharklet (R) Silicone Foley Catheter | 2018 | 0 |
| K101824 | Amsure 3-Way Hydrophilic Latex Foley Catheter | 2010 | 0 |
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 18 years and passes through 2 companies; a new generation was cleared every 10.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K233094 (Well Lead Medical (Hainan) Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K981612.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Two - Way Catheters - Urethral catheterization for bladder drainage for urological use only.
Three - Way Catheters - Urethral catheterization for bladder drainage and bladder irrigation for urological use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082815: Well Lead Silicone and Latex Foley Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082815
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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