# K243175: Disposable Intermittent Catheter (TPU Catheter)

- Pathway: 510(k) (Traditional)
- Applicant: Chengdu Daxan Innovative Medical Tech. Co., Ltd.
- Decided: Jun 26, 2025 after 269 days
- Product code: EZD (Catheter, Straight)
- 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: 3 generations back to K000070 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200134: Jimushi Sterile Urethral Catheter for single use, Hangzhou Jimushi Meditech Co., Ltd. (2020) Summary page 5.

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

Source page: https://510kreport.com/device/K243175
Methodology: https://510kreport.com/methodology