Cleared Traditional

K904386 - UROLAB JANUS (FDA 510(k) Clearance)

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

K904386 · Life-Tech Intl., Inc. · Gastroenterology & Urology device
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Nov 1990
Decision
64d
Days
Class 2
Risk

K904386 is an FDA 510(k) clearance for the UROLAB JANUS. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Life-Tech Intl., Inc. (Houston, US). The FDA issued a Cleared decision on November 27, 1990 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Life-Tech Intl., Inc. devices

Submission Details

510(k) Number K904386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1990
Decision Date November 27, 1990
Days to Decision 64 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
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device
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.