510(k) · Cleared
ClearedGentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec Limited · EZD Catheter, Straight
Cleared on Apr 1, 2026 as substantially equivalent to K213283 (Convatec Limited, 2022) and 2 other predicates after a 198-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Apr 1, 2026
- Review
- 198 days
- Class
- Class II
- Product code
- EZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K896750 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK896750 Lofric (R), Lofric (R) Cath-KitAstra Meditec AB · 1990
- 4 generations backK050874 Astra Tech AB Lofric Primo Single Use Urinary CatheterAstra Tech, Inc. · 2005
- 3 generations backK161344 GentleCath Glide Intermittent CatheterConvatec Limited · 2016
- 2 generations backK181206 GentleCath Glide Intermittent Urinary CatheterConvatec Limited · 2018
- 1 generation backK213283 GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited · 2022
- This deviceK252943 GentleCath Air for Men; GentleCath Glide Intermittent Catheter…Convatec Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896750 | Lofric (R), Lofric (R) Cath-Kit | Astra Meditec AB | 1990 | — |
| −4 | K050874 | Astra Tech AB Lofric Primo Single Use Urinary Catheter | Astra Tech, Inc. | 2005 | — |
| −3 | K161344 | GentleCath Glide Intermittent Catheter | Convatec Limited | 2016 | — |
| −2 | K181206 | GentleCath Glide Intermittent Urinary Catheter | Convatec Limited | 2018 | — |
| −1 | K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | Convatec Limited | 2022 | — |
| 0 (this device) | 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 |
| 2024 | 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 EZD? 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 EZD device
- #1 K241210 Luja Coudescore 16.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterSummary page 5…ical catheter and accessories Device Classification Class II Classification Regulation 21 CFR 876.5130 Predicate Devices GentleCath Air for Men (K213283) GentleCath Glide Intermittent Catheter (K181206) GentleCath Air for… | 2022 |
| * | K181206 | GentleCath Glide Intermittent Urinary CatheterSummary page 5…ation Regulation 21 CFR 876.5130 Predicate Devices GentleCath Air for Men (K213283) GentleCath Glide Intermittent Catheter (K181206) GentleCath Air for Women (K232665) Device Description The subject intermittent catheters… | 2018 |
| * | K232665 | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for…Summary page 5…GentleCath Air for Men (K213283) GentleCath Glide Intermittent Catheter (K181206) GentleCath Air for Women (K232665) Device Description The subject intermittent catheters are the same or slightly modified fro… | 2024 |
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 36 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All EZD devicesEZD Catheter, Straight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · EZD
11so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EZD
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZD
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EZD
288in 2025
MAUDE reports naming product code EZD, 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 | 4 | 121 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 4 |
| 2010 | 2 | — | 0 | 6 |
| 2011 | 4 | 116 | 1 | 4 |
| 2012 | 2 | — | 1 | 2 |
| 2013 | 4 | 110 | 0 | 18 |
| 2014 | 5 | 91 | 1 | 17 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 3 | 83 | 0 | 21 |
| 2017 | 2 | — | 0 | 120 |
| 2018 | 3 | 122 | 0 | 390 |
| 2019 | 0 | — | 0 | 466 |
| 2020 | 1 | — | 0 | 563 |
| 2021 | 0 | — | 0 | 994 |
| 2022 | 10 | 288 | 0 | 487 |
| 2023 | 6 | 214 | 0 | 553 |
| 2024 | 5 | 147 | 0 | 116 |
| 2025 | 6 | 130 | 0 | 288 |
| 2026 | 11 | 146 | 0 | — |
What is it indicated for?
GentleCath™ Air for Men: Intermittent drainage of the urinary bladder of adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.
GentleCath™ Glide Intermittent Catheter: Intermittent drainage of the urinary bladder of adults and pediatric patients who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.
GentleCath™ Air for Women: Intermittent drainage of the urinary bladder of females who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252943 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252943: GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252943
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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