# K250448: Disposable Percutaneous Nephrostomy Dilatation Kit

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Trious Medical Technology Co., Ltd.
- Decided: Jul 3, 2025 after 135 days
- Product code: LJE (Catheter, Nephrostomy)
- Device class: U
- 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 K961904 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170531: Ureteral Dilators and Percutaneous Nephrostomy Dilators, Coloplast Corp. (2017) Summary page 5.

## Indications for use
Disposable Percutaneous Nephrostomy Dilators: Dilator for tract preparation and splittable working sheath to protect the parenchyma.

Source page: https://510kreport.com/device/K250448
Methodology: https://510kreport.com/methodology