510(k) · Cleared
ClearedGentleCath Glide Intermittent Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec Limited · KOD Catheter, Urological
Cleared on Sep 20, 2016 as substantially equivalent to K000070 (Rusch Intl., 2000) and 1 other predicate after a 130-day review. Its family tree reaches back 2 generations to 1990. 4 later devices descend from it.
- Decided
- Sep 20, 2016
- Review
- 130 days
- Class
- Class II
- Product code
- KOD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K896750 (1990). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK896750 Lofric (R), Lofric (R) Cath-KitAstra Meditec AB · 1990
- 1 generation backK050874 Astra Tech AB Lofric Primo Single Use Urinary CatheterAstra Tech, Inc. · 2005
- This deviceK161344 GentleCath Glide Intermittent CatheterConvatec Limited · 2016
- Descendant · cites it directly · 3 of its ownK181206 GentleCath Glide Intermittent Urinary CatheterConvatec Limited · 2018
- Descendant · 2 generations on · 1 of its ownK232665 GentleCath Air for Women (CH10); GentleCath Air for Women (CH12)…Convatec · 2024
- Descendant · 2 generations on · 1 of its ownK213283 GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited · 2022
- Descendant · 2 generations on · 0 of its ownK252943 GentleCath Air for Men; GentleCath Glide Intermittent Catheter…Convatec Limited · 2026
Most influential descendants
Showing 4 of 4 · See all- K181206GentleCath Glide Intermittent Urinary CatheterConvatec Limited · 2018 · cites it directly3descendants
- K232665GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for…Convatec · 2024 · 2 generations on1descendant
- K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited · 2022 · 2 generations on1descendant
- K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenConvatec Limited · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896750 | Lofric (R), Lofric (R) Cath-Kit | Astra Meditec AB | 1990 | — |
| −1 | K050874 | Astra Tech AB Lofric Primo Single Use Urinary Catheter | Astra Tech, Inc. | 2005 | — |
| 0 (this device) | K161344 | GentleCath Glide Intermittent Catheter | Convatec Limited | 2016 | — |
| +1 | K181206 | GentleCath Glide Intermittent Urinary Catheter | Convatec Limited | 2018 | — |
| +2 | K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath… | Convatec | 2024 | — |
| +2 | K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | Convatec Limited | 2022 | — |
| +2 | K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air… | Convatec Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K000070 | FlocathSummary page 5…K161344 Page 2 of 8 Predicate Devices: 510(K) number: K000070 Rüsch FloCath Quick 510(k) number: K050874 LoFric Primo Device Description A hydrophilic urological catheter is a flexible… | 2000 |
| * | K050874 | Astra Tech AB Lofric Primo Single Use Urinary CatheterSummary page 5…Page 2 of 8 Predicate Devices: 510(K) number: K000070 Rüsch FloCath Quick 510(k) number: K050874 LoFric Primo Device Description A hydrophilic urological catheter is a flexible tubular device that is inserted through the u… | 2005 |
| † | K140953 | Gentlecath Male Coude Olive Tip Intermittent Urinary Catheter | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181206 | GentleCath Glide Intermittent Urinary Catheter | 2018 | 3 |
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 26 years and passes through 3 companies; a new generation was cleared every 14.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K181206 (Convatec Limited, 2018) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K000070.
How does its category compare?
All KOD devicesKOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 indicated for routine transient intermittent drainage of the bladder. The catheter is inserted through the urethra.
GentleCath Glide intermittent catheter is intended for adult use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161344: GentleCath Glide Intermittent Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161344
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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