Cleared Traditional

K842024 - ULTRASONIC LITHOTRIPTOR 300A

K842024 is an FDA 510(k) clearance for ULTRASONIC LITHOTRIPTOR 300A, manufactured by Fibra Sonics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FEO cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K842024 · Fibra Sonics, Inc. · Gastroenterology & Urology device
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Dec 1984
Decision
207d
Days
Class 2
Risk

K842024 is an FDA 510(k) clearance for the ULTRASONIC LITHOTRIPTOR 300A. Classified as Lithotriptor, Ultrasonic (product code FEO), Class II - Special Controls.

Submitted by Fibra Sonics, Inc. (Chicago, US). The FDA issued a Cleared decision on December 11, 1984 after a review of 207 days - an extended review cycle.

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. 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 Fibra Sonics, Inc. devices

FDA 510(k) Submission Details - K842024

510(k) Number K842024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1984
Decision Date December 11, 1984
Days to Decision 207 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 130d · This submission: 207d
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 10
Devices cleared under the same product code (FEO) and FDA review panel - the closest regulatory comparables to K842024.
ULTRASOUND GENERATOR MODLE 2270
K920235 · Richard Wolf Medical Instruments Corp. · Dec 1992
OLYMPUS LUS ULTRASONIC LITHOTRIPTER
K873367 · Olympus Corp. · Nov 1987
ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM
K850298 · Cabot Medical Corp. · Mar 1985
KARL STORZ 27086KC ULTRASONIC LITHOTRI
K843101 · KARL STORZ Endoscopy-America, Inc. · Dec 1984