Cleared Traditional

K920410 - EMILITH ELECTROMECHANICALIMPACTOR LITHO...

K920410 is an FDA 510(k) clearance for EMILITH ELECTROMECHANICALIMPACTOR LITHO..., manufactured by Psi Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Traditional 510(k) pathway after a 745-day FDA review.

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

FDA 510(k) Submission Details - K920410

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.

FFK Device Classification - Class 2, Special Controls

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 31
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K920410.
MICROVASIVE LIPTHOTRIPSY PROBES
K973788 · Boston Scientific Corp · Jan 1998
PULSE GUARD 3FR ELECTRODE
K944571 · Northgate Technologies, Inc. · Mar 1995
RIWOLITH 2280 PROBES
K931755 · Richard Wolf Medical Instruments Corp. · Apr 1994
PULSE GUARD ELECTRODE
K925396 · Northgate Technologies, Inc. · Jul 1993
AUTOLITH-IEHL
K923822 · Northgate Technologies, Inc. · Jan 1993
SD-200IEHL(TM)
K914517 · Northgate Technologies, Inc. · Jun 1992