Cleared Traditional

K040741 - ULTRASOUND LOCALIZATION SYSTEM ULS 0142

K040741 is an FDA 510(k) clearance for ULTRASOUND LOCALIZATION SYSTEM ULS 0142, manufactured by Hmt High Medical Technologies AG. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K040741 · Hmt High Medical Technologies AG · Gastroenterology & Urology device
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Aug 2004
Decision
149d
Days
Class 2
Risk

K040741 is an FDA 510(k) clearance for the ULTRASOUND LOCALIZATION SYSTEM ULS 0142. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Hmt High Medical Technologies AG (Washington, US). The FDA issued a Cleared decision on August 19, 2004 after a review of 149 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 Hmt High Medical Technologies AG devices

FDA 510(k) Submission Details - K040741

510(k) Number K040741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2004
Decision Date August 19, 2004
Days to Decision 149 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
19d slower than avg
Panel avg: 130d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNS Device Classification - Class 2, Special Controls

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 18
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K040741.
MODULARIS VARIOSTAR
K070799 · Siemens Medical Solutions USA, Inc. · Nov 2007
STORZ SLX-F2 STORM TOUCH
K070579 · KARL STORZ Endoscopy-America, Inc. · Aug 2007
STORZ MODULITH, MODEL SLX-F2
K040476 · KARL STORZ Endoscopy-America, Inc. · Aug 2004
MODULITH SLK LITHOTRIPTER
K011700 · Karl Storz Endoscopy · Aug 2002
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
K012482 · KARL STORZ Endoscopy-America, Inc. · Oct 2001
DORNIER COMPACT ALPHA LITHOTRIPTER
K002929 · Dornier Medtech America, Inc. · Apr 2001