Cleared Traditional

COMFORTCARE SYSTEM (K933126) - FDA 510(k) Clearance

Class I Gastroenterology & Urology device.

K933126 · Patsy J. Trisler, J.D. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
242d
Days
Class 1
Risk

K933126 is an FDA 510(k) clearance for the COMFORTCARE SYSTEM. Classified as System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile (product code EYZ), Class I - General Controls.

Submitted by Patsy J. Trisler, J.D. (Rockville, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 242 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5250 - 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 Patsy J. Trisler, J.D. devices

Submission Details

510(k) Number K933126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1993
Decision Date February 25, 1994
Days to Decision 242 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
112d slower than avg
Panel avg: 130d · This submission: 242d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EYZ System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5250
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.