Cleared Traditional

K903395 - UROMAT 2000

K903395 is an FDA 510(k) clearance for UROMAT 2000, manufactured by Pausch Corp.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K903395 · Pausch Corp. · Radiology device
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Aug 1990
Decision
34d
Days
Class 2
Risk

K903395 is an FDA 510(k) clearance for the UROMAT 2000. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Pausch Corp. (Little Silver, US). The FDA issued a Cleared decision on August 30, 1990 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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.

FDA 510(k) Submission Details - K903395

510(k) Number K903395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1990
Decision Date August 30, 1990
Days to Decision 34 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 107d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXR Device Classification - Class 2, Special Controls

Product Code IXR Table, Radiographic, Tilting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 Peers - IXR Table, Radiographic, Tilting

All 76
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K903395.
MTT 90 UNIVERSAL REMOTE-CONTROLLED X-RAY TABLE
K901654 · Imt America, Inc. · Nov 1990
G.E. MONITROL 90 AND G.E. MONITROL 15
K902989 · Electromek Diagnostic Systems, Inc. · Oct 1990
MT-15 RADIOGRAPHIC/FLUOROSCOPIC TILT TABLE
K903422 · Imt America, Inc. · Sep 1990
F.A.S.T. TABLE
K896583 · Oec-Diasonics, Inc. · Mar 1990
RMS 90/15 RADIOGRAPHIC/FLUOROSCOPIC TILTING TABLE
K896119 · Rms Div. · Nov 1989
ELITE 1500 RADIOGRAPHIC TILTING TABLE
K896324 · Rms Div. · Nov 1989
K903395 · UROMAT 2000
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