Cleared Traditional

K955019 - UROTRACT I (FDA 510(k) Clearance)

Class I Radiology device.

K955019 · Dornier Medtech America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
34d
Days
Class 1
Risk

K955019 is an FDA 510(k) clearance for the UROTRACT I. Classified as Table, Cystometric, Non-electric And Accessories (product code KQS), Class I - General Controls.

Submitted by Dornier Medtech America, Inc. (Kennesaw, US). The FDA issued a Cleared decision on December 6, 1995 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 876.4890 - the FDA radiology and imaging software oversight 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 Dornier Medtech America, Inc. devices

Submission Details

510(k) Number K955019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1995
Decision Date December 06, 1995
Days to Decision 34 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 107d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQS Table, Cystometric, Non-electric And Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.4890
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.