Cleared Special

“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) (K243045) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243045 · Braxx Biotech Co., Ltd. · Radiology device
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Optimized for regulatory review, auditing and printing
Nov 2024
Decision
53d
Days
Class 2
Risk

K243045 is an FDA 510(k) clearance for the “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002). Classified as System, Applicator, Radionuclide, Remote-controlled (product code JAQ), Class II - Special Controls.

Submitted by Braxx Biotech Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on November 19, 2024 after a review of 53 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. 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.

View all Braxx Biotech Co., Ltd. devices

Submission Details

510(k) Number K243045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2024
Decision Date November 19, 2024
Days to Decision 53 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
54d faster than avg
Panel avg: 107d · This submission: 53d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Consultant

ZhengCheng Consulting Limited Company
Anita Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JAQ System, Applicator, Radionuclide, Remote-controlled

All 71
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