Cleared Traditional

K043336 - OPTISTRAND, MODEL 1032S

K043336 is an FDA 510(k) clearance for OPTISTRAND, manufactured by Ibt SA. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K043336 · Ibt SA · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
49d
Days
Class 2
Risk

K043336 is an FDA 510(k) clearance for the OPTISTRAND, MODEL 1032S. 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 January 21, 2005 after a review of 49 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.

FDA 510(k) Submission Details - K043336

510(k) Number K043336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2004
Decision Date January 21, 2005
Days to Decision 49 days
Submission Type Traditional
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
58d faster than avg
Panel avg: 107d · This submission: 49d
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 150
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K043336.
NSTRAND IMPLANTATION KIT
K052024 · North American Scientific, Inc. · Sep 2005
BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
K043246 · C.R. Bard, Inc. · Feb 2005
THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06
K043596 · Theragenics Corp. · Jan 2005
IMPLANT SCIENCES CORP, MODEL HDR-4140
K042864 · Implant Sciences Corp. · Jan 2005
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
K043336 · OPTISTRAND, MODEL 1032S
Download PDF FDA Summary Ibt SA