Cleared Traditional

K132097 - BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY

K132097 is an FDA 510(k) clearance for BEST MULTI-LUMEN BALLOON APPLICATOR FOR..., manufactured by Best Medical International, Inc.. The device is a Class 2 Radiology device with product code JAQ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K132097 · Best Medical International, Inc. · Radiology device
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Sep 2013
Decision
84d
Days
Class 2
Risk

K132097 is an FDA 510(k) clearance for the BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY. Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Best Medical International, Inc. (Springfield, US). The FDA issued a Cleared decision on September 30, 2013 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5700 - 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 - K132097

510(k) Number K132097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2013
Decision Date September 30, 2013
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAQ Device Classification - Class 2, Special Controls

Product Code JAQ System, Applicator, Radionuclide, Remote-controlled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5700
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 - JAQ System, Applicator, Radionuclide, Remote-controlled

All 169
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