510(k) · Cleared
ClearedWellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Well Lead Medical Co., Ltd. · GBM Catheter, Urethral
Cleared on Mar 5, 2025 as substantially equivalent to K180258 (Coloplast, 2018) and 1 other predicate after a 261-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Mar 5, 2025
- Review
- 261 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K910022 (1991). 8 ancestors in all, the oldest K896750 (1990). No later device cites it as a predicate yet.
- Root · 5 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 4 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 3 generations backK023254 SpeedicathColoplast Corp. · 2003
- 2 generations backK072808 Speedicath CompactColoplast Corp. · 2007
- 1 generation backK203637 SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact…Coloplast · 2022
- This deviceK241734 Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead®…Well Lead Medical Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −4 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −3 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| −2 | K072808 | Speedicath Compact | Coloplast Corp. | 2007 | — |
| −1 | K203637 | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus… | Coloplast | 2022 | — |
| 0 (this device) | K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic… | Well Lead Medical Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
| 2018 | 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 GBM? 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 GBM device
- #1 K200134 Jimushi Sterile Urethral Catheter for single usescore 8.7 · 2 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 |
|---|---|---|---|
| * | K180258 | SpeediCath StandardSummary page 5…ice Sponsor Coloplast Corp Device Name SpeediCath Standard 510(k) Number K180258 Product Code GBM Regulation Number 21 CFR 876.5130 Regulation… | 2018 |
| * | K203637 | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812…Summary page 6…SpeediCath Compact Device Name SpeediCath Compact Plus 510(k) Number K203637 Product Code EZD Regulation Number 21 CFR 876.5130 Regulati… | 2022 |
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 34 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GBM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GBM
230in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GBM
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBM
311in 2025
MAUDE reports naming product code GBM, 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 | 2 | — | 0 | 5 |
| 2008 | 0 | — | 5 | 18 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 2 | — | 1 | 46 |
| 2012 | 3 | 139 | 0 | 32 |
| 2013 | 0 | — | 0 | 41 |
| 2014 | 1 | — | 0 | 19 |
| 2015 | 5 | 76 | 0 | 21 |
| 2016 | 3 | 112 | 0 | 49 |
| 2017 | 2 | — | 0 | 59 |
| 2018 | 6 | 93 | 0 | 82 |
| 2019 | 7 | 121 | 0 | 148 |
| 2020 | 6 | 230 | 0 | 144 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 2 | — | 0 | 283 |
| 2023 | 0 | — | 1 (1) | 202 |
| 2024 | 0 | — | 0 | 468 |
| 2025 | 1 | — | 1 | 311 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Hydrophilic Intermittent Catheter is used to empty the bladder for patients with urinary retention or incomplete bladder emptying.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241734: Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241734
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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