Cleared Traditional

K852856 - LABORIE URODYNAMICS PROCESSOR

K852856 is an FDA 510(k) clearance for LABORIE URODYNAMICS PROCESSOR, manufactured by Tridak Division of Indicon, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAP cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K852856 · Tridak Division of Indicon, Inc. · Gastroenterology & Urology device
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Oct 1985
Decision
104d
Days
Class 2
Risk

K852856 is an FDA 510(k) clearance for the LABORIE URODYNAMICS PROCESSOR. Classified as Cystometric Gas (carbon-dioxide) On Hydraulic Device (product code FAP), Class II - Special Controls.

Submitted by Tridak Division of Indicon, Inc. (Pearl River, US). The FDA issued a Cleared decision on October 17, 1985 after a review of 104 days - within the typical 510(k) review window.

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 Tridak Division of Indicon, Inc. devices

FDA 510(k) Submission Details - K852856

510(k) Number K852856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1985
Decision Date October 17, 1985
Days to Decision 104 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
27d faster than avg
Panel avg: 131d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FAP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FAP Cystometric Gas (carbon-dioxide) On Hydraulic Device

All 40
Devices cleared under the same product code (FAP) and FDA review panel - the closest regulatory comparables to K852856.
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K853936 · Life-Tech Intl., Inc. · Dec 1985
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K850601 · Life-Tech Intl., Inc. · Apr 1985
1870T PRESSURE TRANSDUCER PRE-AMPLIFIER, 1880 WATE
K850602 · Life-Tech Intl., Inc. · Apr 1985
LUMEN-4 URODYNAMIC CATHETER
K833628 · Surgitek · Nov 1983