Cleared Traditional

K960104 - BIOCCLUS 4

K960104 is an FDA 510(k) clearance for BIOCCLUS 4, manufactured by Degussa Corp.. The device is a Class 2 Radiology device with product code EJT cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K960104 · Degussa Corp. · Radiology device
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Feb 1996
Decision
26d
Days
Class 2
Risk

K960104 is an FDA 510(k) clearance for the BIOCCLUS 4. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Degussa Corp. (South Plainfield, US). The FDA issued a Cleared decision on February 6, 1996 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.3060 - 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 Degussa Corp. devices

FDA 510(k) Submission Details - K960104

510(k) Number K960104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date February 06, 1996
Days to Decision 26 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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.