510(k) · Cleared
ClearedGentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec Limited · GBM Catheter, Urethral
Cleared on Jun 22, 2022 as substantially equivalent to K181206 (Convatec Limited, 2018) after a 264-day review. Its family tree reaches back 4 generations to 1990. 1 later device descends from it.
- Decided
- Jun 22, 2022
- Review
- 264 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K896750 (1990). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK896750 Lofric (R), Lofric (R) Cath-KitAstra Meditec AB · 1990
- 3 generations backK050874 Astra Tech AB Lofric Primo Single Use Urinary CatheterAstra Tech, Inc. · 2005
- 2 generations backK161344 GentleCath Glide Intermittent CatheterConvatec Limited · 2016
- 1 generation backK181206 GentleCath Glide Intermittent Urinary CatheterConvatec Limited · 2018
- This deviceK213283 GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited · 2022
- Descendant · cites it directly · 0 of its ownK252943 GentleCath Air for Men; GentleCath Glide Intermittent Catheter…Convatec Limited · 2026
Most influential descendants
Showing 1 of 1 · See all- K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenConvatec Limited · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896750 | Lofric (R), Lofric (R) Cath-Kit | Astra Meditec AB | 1990 | — |
| −3 | K050874 | Astra Tech AB Lofric Primo Single Use Urinary Catheter | Astra Tech, Inc. | 2005 | — |
| −2 | K161344 | GentleCath Glide Intermittent Catheter | Convatec Limited | 2016 | — |
| −1 | K181206 | GentleCath Glide Intermittent Urinary Catheter | Convatec Limited | 2018 | — |
| 0 (this device) | K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | Convatec Limited | 2022 | — |
| +1 | 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 |
|---|---|---|
| 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 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 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K181206 | GentleCath Glide Intermittent Urinary CatheterSummary page 4…II Product Code: GBM (catheter, urethral) Panel: Gastroenterology and Urology Predicate Device: GentleCath Glide Intermittent Catheter, K181206 The predicate device has not been subject to a design related recall… | 2018 |
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 |
|---|---|---|---|
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women | 2026 | 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 32 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K252943 (Convatec Limited, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K181206.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
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
The target population for GC Air for Men is male adults and includes Transitional Adolescents B (18 year old to less than 22 years old but treated like adult).
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/K213283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213283: GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213283
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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