Cleared Abbreviated

K042786 - BEST MODEL # 81-01 SERIES IR-192 SOURCES

K042786 is an FDA 510(k) clearance for BEST MODEL # 81-01 SERIES IR-192 SOURCES, manufactured by Best Medical International, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Abbreviated 510(k) pathway after a 43-day FDA review.

K042786 · Best Medical International, Inc. · Radiology device
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Nov 2004
Decision
43d
Days
Class 2
Risk

K042786 is an FDA 510(k) clearance for the BEST MODEL # 81-01 SERIES IR-192 SOURCES. 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 November 18, 2004 after a review of 43 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Best Medical International, Inc. devices

FDA 510(k) Submission Details - K042786

510(k) Number K042786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2004
Decision Date November 18, 2004
Days to Decision 43 days
Submission Type Abbreviated
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
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Standards-based clearance path.

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 K042786.
OPTISTRAND, MODEL 1032S
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BEST RADIOPAQUE STRAND
K043117 · Best Medical International, Inc. · Dec 2004
EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)
K041702 · Ibt SA · Jul 2004
SOURCELINK
K041576 · C.R. Bard, Inc. · Jul 2004
CP SLEEVE AND RIVER SLEEVE
K034062 · Cp Medical · Jan 2004