Cleared Traditional

K201074 - Delta III Lithotripter

K201074 is the FDA 510(k) clearance for Delta III Lithotripter by Dornier Medtech America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code LNS) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K201074 · Dornier Medtech America, Inc. · Gastroenterology & Urology device
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Sep 2020
Decision
134d
Days
Class 2
Risk

K201074 is an FDA 510(k) clearance for the Delta III Lithotripter. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Dornier Medtech America, Inc. (Kennesaw, US). The FDA issued a Cleared decision on September 3, 2020 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5990 - 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 K201074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2020
Decision Date September 03, 2020
Days to Decision 134 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
4d slower than avg
Panel avg: 130d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNS Lithotriptor, Extracorporeal Shock-wave, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5990
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 - LNS Lithotriptor, Extracorporeal Shock-wave, Urological

All 17
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K201074.
Delta III Pro
K221903 · Dornier Medtech America, Inc. · Feb 2023
LM-9300 Plus Lithotripter
K213772 · Lite-Med, Inc. · Jan 2023
Modulith SLX-F2
K201001 · Karl Storz Endoscopy America · Mar 2021
Delta III Lithotripter
K172084 · Dornier Medtech America, Inc. · Aug 2017
GEMINI LITHOTRIPTER
K121656 · Dornier Medtech America, Inc. · Sep 2012
MODULTH SLK
K120769 · KARL STORZ Endoscopy-America, Inc. · Jun 2012