Cleared Traditional

K021775 - LTFS230

K021775 is an FDA 510(k) clearance for LTFS230, manufactured by Healthtronics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K021775 · Healthtronics, Inc. · Gastroenterology & Urology device
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Dec 2002
Decision
208d
Days
Class 2
Risk

K021775 is an FDA 510(k) clearance for the LTFS230. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Healthtronics, Inc. (Marietta, US). The FDA issued a Cleared decision on December 23, 2002 after a review of 208 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 Healthtronics, Inc. devices

FDA 510(k) Submission Details - K021775

510(k) Number K021775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2002
Decision Date December 23, 2002
Days to Decision 208 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
77d slower than avg
Panel avg: 131d · This submission: 208d
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 53
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K021775.
PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
K032958 · United Medical Systems, Inc. · Feb 2004
TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K030346 · Fmd, LLC · May 2003
TRIPTER X-1 COMPACT DUET
K023535 · Direx Systems Corp. · Jan 2003
MODULITH SLK LITHOTRIPTER
K011700 · Karl Storz Endoscopy · Aug 2002
DELTA 2000 SERIES EXTRACORPOREAL LITHOTRIPTER
K013471 · E.S.W.L. Products, Inc. · Apr 2002
STONELITH, MODEL V5
K011106 · Pck Electronic Industry and Trade Co, Ltd. · Feb 2002