# K132097: Best Multi-Lumen Balloon Applicator for Brachytherapy

- Pathway: 510(k) (Traditional)
- Applicant: Best Medical International, Inc.
- Decided: Sep 30, 2013 after 84 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: 8 generations back to K864210 (1986). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081079: Contura MLB Source Applicator for Brachytherapy, Senorx, Inc. (2008) Summary page 1.

## Indications for use
Best® Multi-Lumen Balloon Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy for breast cancer. It is supplied as a single-use sterile device. The device is indicated for use under the direct supervision of a qualified physician. The safety and effectiveness of The Best Multi-Lumen Balloon Applicator for Brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

Source page: https://510kreport.com/device/K132097
Methodology: https://510kreport.com/methodology