Cleared Traditional

K101482 - EM-9000

K101482 is an FDA 510(k) clearance for EM-9000, manufactured by Elite Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K101482 · Elite Medical, Inc. · Gastroenterology & Urology device
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Mar 2011
Decision
307d
Days
Class 2
Risk

K101482 is an FDA 510(k) clearance for the EM-9000. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Elite Medical, Inc. (Atlanta, US). The FDA issued a Cleared decision on March 31, 2011 after a review of 307 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Elite Medical, Inc. devices

FDA 510(k) Submission Details - K101482

510(k) Number K101482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2010
Decision Date March 31, 2011
Days to Decision 307 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
176d slower than avg
Panel avg: 131d · This submission: 307d
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 41
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K101482.
DUET MAGNA
K111947 · Direx Systems Corp. · Mar 2012
LITE-MED LM-9200 ELMA
K103217 · Lite-Med, Inc. · Sep 2011
SONOLITH I-MOVE
K111808 · Edap Tms France · Aug 2011
SONOLITH I-SYS LITHOTRIPER
K083614 · Technomed Medical Systems, SA · Jul 2009
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER
K072538 · United Medical Systems, Inc. · Jan 2008
LITHOSKOP
K070665 · Siemens Medical Solutions USA, Inc. · Jan 2008