Cleared Traditional

K040339 - BRACHYTHERAPY STRAND DEVICE

K040339 is an FDA 510(k) clearance for BRACHYTHERAPY STRAND DEVICE, manufactured by Bebig Isotopen-Und Medizintechnik GmbH. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K040339 · Bebig Isotopen-Und Medizintechnik GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
57d
Days
Class 2
Risk

K040339 is an FDA 510(k) clearance for the BRACHYTHERAPY STRAND DEVICE. 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 April 8, 2004 after a review of 57 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. 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 Bebig Isotopen-Und Medizintechnik GmbH devices

FDA 510(k) Submission Details - K040339

510(k) Number K040339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2004
Decision Date April 08, 2004
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K040339.
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
K060636 · C.R. Bard, Inc. · Apr 2006
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