Cleared Traditional

C3 EXTERNAL MALE BLADDER CONTROL DEVICE (K974040) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K974040 · Timm Research Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
263d
Days
Class 1
Risk

K974040 is an FDA 510(k) clearance for the C3 EXTERNAL MALE BLADDER CONTROL DEVICE. Classified as Clamp, Penile (product code FHA), Class I - General Controls.

Submitted by Timm Research Co. (Eden Prairie, US). The FDA issued a Cleared decision on July 14, 1998 after a review of 263 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5160 - 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 Timm Research Co. devices

Submission Details

510(k) Number K974040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1997
Decision Date July 14, 1998
Days to Decision 263 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
133d slower than avg
Panel avg: 130d · This submission: 263d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FHA Clamp, Penile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5160
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.