Cleared Special

K033781 - BEBIG ISOSEED I-125

K033781 is an FDA 510(k) clearance for BEBIG ISOSEED I-125, manufactured by Bebig Isotopen-Und Medizintechnik GmbH. The device is a Class 2 Radiology device with product code KXK cleared through the Special 510(k) pathway after a 26-day FDA review.

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

FDA 510(k) Submission Details - K033781

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.

KXK Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KXK Source, Brachytherapy, Radionuclide

All 65
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K033781.
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246 · C.R. Bard, Inc. · Feb 2005
SOURCELINK
K041576 · C.R. Bard, Inc. · Jul 2004
CP SLEEVE AND RIVER SLEEVE
K034062 · Cp Medical · Jan 2004
VARISEED 7.1
K030534 · Varian Medical Systems · May 2003
GAMMAMED 212 AND 232 SOURCE ASSEMBLY
K030745 · Varian Medical Systems · Mar 2003
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
K021311 · Cp Medical · Jul 2002