Cleared Traditional

K954093 - LUMAX (MODIFICATION)

K954093 is an FDA 510(k) clearance for LUMAX (MODIFICATION), manufactured by Medamicus, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FEN cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K954093 · Medamicus, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Jan 1996
Decision
155d
Days
Class 2
Risk

K954093 is an FDA 510(k) clearance for the LUMAX (MODIFICATION). Classified as Device, Cystometric, Hydraulic (product code FEN), Class II - Special Controls.

Submitted by Medamicus, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 11, 1996 after a review of 155 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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 Medamicus, Inc. devices

FDA 510(k) Submission Details - K954093

510(k) Number K954093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1995
Decision Date January 11, 1996
Days to Decision 155 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 130d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FEN Device Classification - Class 2, Special Controls

Product Code FEN Device, Cystometric, Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 - FEN Device, Cystometric, Hydraulic

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