Cleared Traditional

K852083 - THE KENDALL URINARY OUTPUT MONITOR (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K852083 · The Kendal Co. · Gastroenterology & Urology device
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Sep 1985
Decision
130d
Days
Class 1
Risk

K852083 is an FDA 510(k) clearance for the THE KENDALL URINARY OUTPUT MONITOR. Classified as Retractor, Self-retaining (product code FFO), Class I - General Controls.

Submitted by The Kendal Co. (Boston, US). The FDA issued a Cleared decision on September 20, 1985 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4730 - 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 The Kendal Co. devices

Submission Details

510(k) Number K852083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1985
Decision Date September 20, 1985
Days to Decision 130 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
At panel average
Panel avg: 130d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FFO Retractor, Self-retaining
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4730
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.