Cleared Traditional

K250448 - Disposable Percutaneous Nephrostomy Dilatation Kit (FDA 510(k) Clearance)

K250448 · Shenzhen Trious Medical Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
135d
Days
-
Risk

K250448 is an FDA 510(k) clearance for the Disposable Percutaneous Nephrostomy Dilatation Kit. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Shenzhen Trious Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 3, 2025 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Trious Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K250448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2025
Decision Date July 03, 2025
Days to Decision 135 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 130d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJE Catheter, Nephrostomy
Device Class -

Regulatory Consultant

Landlink Healthcare Technology (Shanghai) Co., Ltd.
Kang Kyra

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LJE Catheter, Nephrostomy

All 55
Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K250448.
Introducer Needle
K222705 · Youcare Technology Co.,Ltd. (Wuhan) · May 2023
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
K211911 · Coloplast Corp. · Mar 2022
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
K191498 · Cook Incorporated · Jan 2020