Cleared Special

K041702 - EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)

K041702 is an FDA 510(k) clearance for EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.), manufactured by Ibt SA. The device is a Class 2 Radiology device with product code KXK cleared through the Special 510(k) pathway after a 24-day FDA review.

K041702 · Ibt SA · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
24d
Days
Class 2
Risk

K041702 is an FDA 510(k) clearance for the EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.). Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Ibt SA (Norcross, US). The FDA issued a Cleared decision on July 16, 2004 after a review of 24 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.

FDA 510(k) Submission Details - K041702

510(k) Number K041702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2004
Decision Date July 16, 2004
Days to Decision 24 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 107d · This submission: 24d
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 150
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K041702.
BEST RADIOPAQUE STRAND
K043117 · Best Medical International, Inc. · Dec 2004
BEST MODEL # 81-01 SERIES IR-192 SOURCES
K042786 · Best Medical International, Inc. · Nov 2004
OPTISOURCE, MODEL 1032P
K040766 · International Brachytherapy S.A. · Jul 2004
SOURCELINK
K041576 · C.R. Bard, Inc. · Jul 2004
ISOAID ADVANTAGE PD-103, MODEL IAPD-103A
K033770 · Isoaid, LLC · Apr 2004
BRACHYTHERAPY STRAND DEVICE
K040339 · Bebig Isotopen-Und Medizintechnik GmbH · Apr 2004
K041702 · EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)
Download PDF FDA Summary Ibt SA