Cleared Traditional

EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB (K920410) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K920410 · Psi Medical Products, Inc. · Gastroenterology & Urology device
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Feb 1994
Decision
745d
Days
Class 2
Risk

K920410 is an FDA 510(k) clearance for the EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Psi Medical Products, Inc. (Shelton, US). The FDA issued a Cleared decision on February 14, 1994 after a review of 745 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Psi Medical Products, Inc. devices

Submission Details

510(k) Number K920410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1992
Decision Date February 14, 1994
Days to Decision 745 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
615d slower than avg
Panel avg: 130d · This submission: 745d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFK Lithotriptor, Electro-hydraulic
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 - FFK Lithotriptor, Electro-hydraulic

All 9
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K920410.
MICROVASIVE LITHOTRIPTOR FLEXPROBE II
K002084 · Boston Scientific Corp · Jul 2000
KSEA CALCUSPLIT
K981233 · KARL STORZ Endoscopy-America, Inc. · Jun 1998
MICROVASIVE LIPTHOTRIPSY PROBES
K973788 · Boston Scientific Corp · Jan 1998
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
K883189 · KARL STORZ Endoscopy-America, Inc. · Feb 1989