510(k) · Cleared
ClearedGentlecath Male Coude Olive Tip Intermittent Urinary Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, Ltd. · KOD Catheter, Urological
Cleared on Aug 1, 2014 as substantially equivalent to K896729 (Unoplast A/S, 1990) and 1 other predicate after a 109-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Aug 1, 2014
- Review
- 109 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003784 (2001). 3 ancestors in all, the oldest K896729 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK003784 Mentor Self-Cath PlusMentor Corp. · 2001
- 1 generation backK100878 Self Cath CatheterColoplast Manufacturing Us, LLC · 2010
- This deviceK140953 Gentlecath Male Coude Olive Tip Intermittent Urinary CatheterConvatec, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK172924 GentleCath Intermittent Urinary CatheterConvatec Limited · 2017
Most influential descendants
Showing 1 of 1 · See all- K172924GentleCath Intermittent Urinary CatheterConvatec Limited · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003784 | Mentor Self-Cath Plus | Mentor Corp. | 2001 | — |
| −1 | K100878 | Self Cath Catheter | Coloplast Manufacturing Us, LLC | 2010 | — |
| 0 (this device) | K140953 | Gentlecath Male Coude Olive Tip Intermittent Urinary Catheter | Convatec, Ltd. | 2014 | — |
| +1 | K172924 | GentleCath Intermittent Urinary Catheter | Convatec Limited | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 KOD? 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 KOD device
- #1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · 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 |
|---|---|---|---|
| * | K896729 | Nelaton-, Female - or Tiemann CatheterSummary page 5…gistered Office: ConvaTec GDC, First Avenue, Oeesid% industrial Park, Deeside, Flinishire CHS ZNU K140953 Page 2 of 3 Predicate Devices: 510(k) number: K896729 GentleCath Male Tiemann Intermittent Urinary Catheter (formerly known as Unoplast Nelaton-, Female- or Tiemann Catheter) Product… | 1990 |
| * | K100878 | Self Cath CatheterSummary page 5…nt Urinary Catheter (formerly known as Unoplast Nelaton-, Female- or Tiemann Catheter) Product reference: 501011, 501012, 501013, 501014, 501015, 501016 510(k) number: K100878 Self-Cath Olive Tip Coudé Male Intermittent Urinary Catheter Product reference: 504710/808, 504720/810, 504730/812, 504740/814,… | 2010 |
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 |
|---|---|---|---|
| K172924 | GentleCath Intermittent Urinary Catheter | 2017 | 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 13 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K172924 (Convatec Limited, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K896729.
How does its category compare?
All KOD devicesKOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KOD
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KOD
251in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KOD
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KOD
1,389in 2025
MAUDE reports naming product code KOD, 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 | 180 |
| 2008 | 2 | — | 0 | 102 |
| 2009 | 1 | — | 15 | 183 |
| 2010 | 1 | — | 1 | 228 |
| 2011 | 2 | — | 47 | 209 |
| 2012 | 0 | — | 2 | 165 |
| 2013 | 0 | — | 0 | 393 |
| 2014 | 1 | — | 0 | 226 |
| 2015 | 0 | — | 0 | 418 |
| 2016 | 2 | — | 1 | 284 |
| 2017 | 1 | — | 0 | 1,873 |
| 2018 | 6 | 251 | 0 | 1,179 |
| 2019 | 1 | — | 1 | 1,167 |
| 2020 | 0 | — | 0 | 1,370 |
| 2021 | 1 | — | 0 | 1,388 |
| 2022 | 2 | — | 3 | 1,280 |
| 2023 | 0 | — | 1 (1) | 1,160 |
| 2024 | 0 | — | 0 | 1,259 |
| 2025 | 0 | — | 0 | 1,389 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Intermittent catheters are single use devices indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140953 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140953: Gentlecath Male Coude Olive Tip Intermittent Urinary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140953
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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