# K213283: GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Convatec Limited
- Decided: Jun 22, 2022 after 264 days
- Product code: GBM (Catheter, Urethral)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K896750 (1990). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181206: GentleCath Glide Intermittent Urinary Catheter, Convatec Limited (2018) Summary page 4.

## Most influential descendants
- K252943: GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women (2026), 0 descendants of its own

## Indications for use
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).

Source page: https://510kreport.com/device/K213283
Methodology: https://510kreport.com/methodology