Cleared Special

K033781 - BEBIG ISOSEED I-125 (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033781 · Bebig Isotopen-Und Medizintechnik GmbH · Radiology device
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Dec 2003
Decision
26d
Days
Class 2
Risk

K033781 is an FDA 510(k) clearance for the BEBIG ISOSEED I-125. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Bebig Isotopen-Und Medizintechnik GmbH (Berlin, DE). The FDA issued a Cleared decision on December 30, 2003 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bebig Isotopen-Und Medizintechnik GmbH devices

Submission Details

510(k) Number K033781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2003
Decision Date December 30, 2003
Days to Decision 26 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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.