# K183461: Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: May 8, 2019 after 145 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: 1 generation back to K000070 (2000). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000070: Flocath, Rusch Intl. (2000) Summary page 4.

## Most influential descendants
- K200134: Jimushi Sterile Urethral Catheter for single use (2020), 3 descendants of its own
- K261418: Liquick X-treme, Liquick X-treme Plus (2026), 0 descendants of its own
- K260394: Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) (2026), 0 descendants of its own
- K251274: EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits (2026), 0 descendants of its own
- K243175: Disposable Intermittent Catheter (TPU Catheter) (2025), 0 descendants of its own

## Indications for use
The Rusch Hydrophilic Intermittent catheters (Rusch FloCath Quick, Rusch FloCath Quick Kit, Rusch FloCath Intermittent Catheter, Rusch MMG H2O PVC Catheter Kit, Rusch MMG H2O Singles) are tubular devices that are inserted through the urethra to pass urine from the bladder.

Source page: https://510kreport.com/device/K183461
Methodology: https://510kreport.com/methodology