510(k) · Cleared
ClearedWellead® Latex Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Medical (Hainan) Co., Ltd. · MJC Catheter, Urological (Antimicrobial) And Accessories
Cleared on Jun 6, 2024 as substantially equivalent to K082815 (Well Lead Medical Instruments, 2008) after a 254-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Jun 6, 2024
- Review
- 254 days
- Class
- Class II
- Product code
- MJC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K896053 (1990). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK896053 All Silicone Foley CatheterRochester Medical Corp. · 1990
- 2 generations backK981612 All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley…Rochester Medical Corp. · 1998
- 1 generation backK082815 Well Lead Silicone and Latex Foley CathetersWell Lead Medical Instruments · 2008
- This deviceK233094 Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK243011 Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896053 | All Silicone Foley Catheter | Rochester Medical Corp. | 1990 | — |
| −2 | K981612 | All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter… | Rochester Medical Corp. | 1998 | — |
| −1 | K082815 | Well Lead Silicone and Latex Foley Catheters | Well Lead Medical Instruments | 2008 | — |
| 0 (this device) | K233094 | Wellead® Latex Foley Catheter | Well Lead Medical (Hainan) Co., Ltd. | 2024 | — |
| +1 | 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 |
|---|---|---|
| 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 MJC? 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? (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 |
|---|---|---|---|
| * | K082815 | Well Lead Silicone and Latex Foley CathetersSummary page 5…EZL Panel: Gastroenterology/Urology 3. PREDICATE AND Predicate: Well Lead Latex Foley Catheters (K082815) REFERENCE DEVICES Reference: Medline Latex Foley Catheter (K071423) IDENTIFICATION Predicate… | 2008 |
| † | K071423 | Medline Latex Foley Catheter | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243011 | Silicone Urethral Catheter (Silicone Urethral Catheter) | 2025 | 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 34 years and passes through 3 companies; a new generation was cleared every 10.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K243011 (Guangdong Ecan Medical Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K082815.
How does its category compare?
All MJC devicesMJC Catheter, Urological (Antimicrobial) And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MJC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MJC
Too few MJC 510(k)s in any year since 2007 to give a median.
Recalls per year · MJC
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJC
3,747in 2025
MAUDE reports naming product code MJC, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 13 |
| 2015 | 0 | — | 1 | 25 |
| 2016 | 0 | — | 1 | 134 |
| 2017 | 0 | — | 0 | 714 |
| 2018 | 0 | — | 2 | 613 |
| 2019 | 0 | — | 0 | 1,270 |
| 2020 | 0 | — | 0 | 1,433 |
| 2021 | 0 | — | 0 | 1,464 |
| 2022 | 0 | — | 0 | 1,796 |
| 2023 | 0 | — | 0 | 1,987 |
| 2024 | 1 | — | 0 | 1,960 |
| 2025 | 0 | — | 0 | 3,747 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Latex Foley Catheter is inserted into the bladder through urethra and are indicated for routine urine drainage or for routine post-operative drainage and bladder irrigation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233094: Wellead® Latex 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/K233094
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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