Cleared Traditional

K920235 - ULTRASOUND GENERATOR MODLE 2270

K920235 is an FDA 510(k) clearance for ULTRASOUND GENERATOR MODLE 2270, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FEO cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K920235 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
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Dec 1992
Decision
325d
Days
Class 2
Risk

K920235 is an FDA 510(k) clearance for the ULTRASOUND GENERATOR MODLE 2270. Classified as Lithotriptor, Ultrasonic (product code FEO), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Vernon Hills, US). The FDA issued a Cleared decision on December 7, 1992 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4480 - 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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K920235

510(k) Number K920235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1992
Decision Date December 07, 1992
Days to Decision 325 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 131d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEO Device Classification - Class 2, Special Controls

Product Code FEO Lithotriptor, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4480
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 - FEO Lithotriptor, Ultrasonic

All 12
Devices cleared under the same product code (FEO) and FDA review panel - the closest regulatory comparables to K920235.
Shock Pulse-SE Lithotripsy System CYBERWAND II
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KSEA CALCUSON
K973251 · KARL STORZ Endoscopy-America, Inc. · Jun 1998
OLYMPUS LUS ULTRASONIC LITHOTRIPTER
K873367 · Olympus Corp. · Nov 1987
ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM
K850298 · Cabot Medical Corp. · Mar 1985
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K843101 · KARL STORZ Endoscopy-America, Inc. · Dec 1984