Cleared Traditional

K941105 - UORCAP

K941105 is an FDA 510(k) clearance for UORCAP, manufactured by Laborie Medical Tech, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code EXY cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K941105 · Laborie Medical Tech, Inc. · Gastroenterology & Urology device
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May 1994
Decision
64d
Days
Class 2
Risk

K941105 is an FDA 510(k) clearance for the UORCAP,MODEL NUMBER UDS-UCAP. Classified as Uroflowmeter (product code EXY), Class II - Special Controls.

Submitted by Laborie Medical Tech, Inc. (Mississauga, CA). The FDA issued a Cleared decision on May 10, 1994 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 876.1800 - 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 Laborie Medical Tech, Inc. devices

FDA 510(k) Submission Details - K941105

510(k) Number K941105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1994
Decision Date May 10, 1994
Days to Decision 64 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
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EXY Device Classification - Class 2, Special Controls

Product Code EXY Uroflowmeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1800
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.