# K000070: Flocath

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Feb 18, 2000 after 39 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 6 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K183461: Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter (2019), 6 descendants of its own
- K062444: HI-Slip and HI-Slip Plus Single Use Hydrophilic Urinary Catheters and Kit (2007), 5 descendants of its own
- K161344: GentleCath Glide Intermittent Catheter (2016), 4 descendants of its own
- K200134: Jimushi Sterile Urethral Catheter for single use (2020), 3 descendants of its own
- K181206: GentleCath Glide Intermittent Urinary Catheter (2018), 3 descendants of its own

## Recalls of this device
- Jul 1, 2019 · Class II · Z-2086-2019: Potential for product not to be sterile.
- May 21, 2014 · Class II · Z-1732-2014: Product was packaged with a straight catheter rather than the correct coude (curved) catheter.

Source page: https://510kreport.com/device/K000070
Methodology: https://510kreport.com/methodology