Cleared Traditional

K002929 - DORNIER COMPACT ALPHA LITHOTRIPTER

K002929 is the FDA 510(k) clearance for DORNIER COMPACT ALPHA 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 209-day FDA review.

K002929 · Dornier Medtech America, Inc. · Gastroenterology & Urology device
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Apr 2001
Decision
209d
Days
Class 2
Risk

K002929 is an FDA 510(k) clearance for the DORNIER COMPACT ALPHA 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 April 17, 2001 after a review of 209 days - an extended review cycle.

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 K002929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2000
Decision Date April 17, 2001
Days to Decision 209 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
79d slower than avg
Panel avg: 130d · This submission: 209d
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.