# K162499: Best Instruminal Applicator

- Pathway: 510(k) (Traditional)
- Applicant: Best Medical International, Inc.
- Decided: Apr 13, 2018 after 583 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: 3 generations back to K912555 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082653: Centering Intraluminal Applicator, Varian Medical Systems, Inc. (2008) Summary page 4.

## Indications for use
Best® Intraluminal Balloon Applicator for Brachytherapy is intended to provide brachytherapy when the physician chooses to deliver intraluminal radiation to an existing body lumen such as the esophagus or bronchus. It is supplied as a single-use sterile device. The device is indicated for use under the direct supervision of a qualified physician.

Source page: https://510kreport.com/device/K162499
Methodology: https://510kreport.com/methodology