Cleared Traditional

K904489 - EUREKA EXTENSION CYLINDERS

K904489 is an FDA 510(k) clearance for EUREKA EXTENSION CYLINDERS, manufactured by Eureka X-Ray Tube Corp.. The device is a Class 2 Radiology device with product code KPW cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K904489 · Eureka X-Ray Tube Corp. · Radiology device
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Oct 1990
Decision
13d
Days
Class 2
Risk

K904489 is an FDA 510(k) clearance for the EUREKA EXTENSION CYLINDERS. Classified as Device, Beam Limiting, X-ray, Diagnostic (product code KPW), Class II - Special Controls.

Submitted by Eureka X-Ray Tube Corp. (Arlington Heights, US). The FDA issued a Cleared decision on October 15, 1990 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1610 - 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 Eureka X-Ray Tube Corp. devices

FDA 510(k) Submission Details - K904489

510(k) Number K904489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1990
Decision Date October 15, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPW Device Classification - Class 2, Special Controls

Product Code KPW Device, Beam Limiting, X-ray, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1610
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 - KPW Device, Beam Limiting, X-ray, Diagnostic

All 7
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