Cleared Traditional

K161019 - Uroview FD

K161019 is an FDA 510(k) clearance for Uroview FD, manufactured by Pausch Medical GmbH. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K161019 · Pausch Medical GmbH · Radiology device
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Aug 2016
Decision
127d
Days
Class 2
Risk

K161019 is an FDA 510(k) clearance for the Uroview FD. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Pausch Medical GmbH (Erlangen, DE). The FDA issued a Cleared decision on August 17, 2016 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pausch Medical GmbH devices

FDA 510(k) Submission Details - K161019

510(k) Number K161019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2016
Decision Date August 17, 2016
Days to Decision 127 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 107d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 Radiology devices follow this clearance model.

Regulatory Consultant

Emergo Global Consulting, LLC
Oliver Eikenberg

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JAA System, X-ray, Fluoroscopic, Image-intensified

All 196
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