Cleared Traditional

K190312 - Dornier Ureteral Stent (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190312 · Dornier Medtech America, Inc. · Gastroenterology & Urology device
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Nov 2019
Decision
276d
Days
Class 2
Risk

K190312 is an FDA 510(k) clearance for the Dornier Ureteral Stent. Classified as Stent, Ureteral (product code FAD), Class II - Special Controls.

Submitted by Dornier Medtech America, Inc. (Kennesaw, US). The FDA issued a Cleared decision on November 15, 2019 after a review of 276 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4620 - the FDA gastroenterology and urology device framework. 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 Dornier Medtech America, Inc. devices

Submission Details

510(k) Number K190312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2019
Decision Date November 15, 2019
Days to Decision 276 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 130d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAD Stent, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FAD Stent, Ureteral

All 121
Devices cleared under the same product code (FAD) and FDA review panel - the closest regulatory comparables to K190312.
Disposable Ureteral Stents
K251890 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Feb 2026
Endura™ Ureteral Stent and Stent Set
K251469 · Cathegenix (Xiamen) Co., Ltd. · Dec 2025
Ureteral Stents (AF-D series)
K243039 · Alton (Shanghai) Medical Instruments Co., Ltd. · Jun 2025
Disposable ureteral stent
K243830 · Shenzhen Trious Medical Technology Co., Ltd. · May 2025
Percuflex Ureteral Stent
K250824 · Boston Scientific Corporation · Apr 2025
RELIEF™ Ureteral Stent Kit
K232920 · Ureteral Stent Company · Mar 2024