Cleared Traditional

K043117 - BEST RADIOPAQUE STRAND

Also marketed or referenced as:
BEST RADIOPAQUE MARKER

K043117 is an FDA 510(k) clearance for BEST RADIOPAQUE STRAND, manufactured by Best Medical International, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K043117 · Best Medical International, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
29d
Days
Class 2
Risk

K043117 is an FDA 510(k) clearance for the BEST RADIOPAQUE STRAND. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Best Medical International, Inc. (Springfield, US). The FDA issued a Cleared decision on December 9, 2004 after a review of 29 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 Best Medical International, Inc. devices

FDA 510(k) Submission Details - K043117

510(k) Number K043117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2004
Decision Date December 09, 2004
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
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 92
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K043117.
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SOURCELINK
K041576 · C.R. Bard, Inc. · Jul 2004