# K243045: “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)

- Pathway: 510(k) (Special)
- Applicant: Braxx Biotech Co., Ltd.
- Decided: Nov 19, 2024 after 53 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K183332 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183332: “BRAXX” Esophageal Brachytherapy Applicator, Braxx Biotech Co., Ltd. (2019) Summary page 5.

## Indications for use
The Esophageal Brachytherapy Applicator is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use.

Source page: https://510kreport.com/device/K243045
Methodology: https://510kreport.com/methodology