# K241734: Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact

- Pathway: 510(k) (Traditional)
- Applicant: Well Lead Medical Co., Ltd.
- Decided: Mar 5, 2025 after 261 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: 5 generations back to K910022 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180258: SpeediCath Standard, Coloplast (2018) Summary page 5.
- K203637: SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814), Coloplast (2022) Summary page 6.

## Indications for use
Hydrophilic Intermittent Catheter is used to empty the bladder for patients with urinary retention or incomplete bladder emptying.

Source page: https://510kreport.com/device/K241734
Methodology: https://510kreport.com/methodology