# K200134: Jimushi Sterile Urethral Catheter for single use

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Jimushi Meditech Co., Ltd.
- Decided: Jun 1, 2020 after 132 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: 2 generations back to K000070 (2000). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183461: Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter, Teleflexmedical, Inc. (2019) Summary page 4.

## Most influential descendants
- K260394: Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) (2026), 0 descendants of its own
- K243175: Disposable Intermittent Catheter (TPU Catheter) (2025), 0 descendants of its own
- K222677: Intermittent nelaton catheter for single use (2023), 0 descendants of its own

## Indications for use
Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.

Source page: https://510kreport.com/device/K200134
Methodology: https://510kreport.com/methodology