# K120344: Radiapak Brachytherapy Applicator Balloon Device

- Pathway: 510(k) (Traditional)
- Applicant: Radiadyne, LLC (Specification Developer)
- Decided: May 3, 2012 after 90 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: 6 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)
- K092822: Capri Applicator, Vivaray, Inc. (2009) Summary page 2.
- K092534: Alatus Vaginal Balloon Packing System, Radiadyne (2009) Summary page 4.

## Indications for use
The RadiaPak Tm Brachytherapy Applicator Balloon Device is a single use, non-sterile, disposable, inflatable, non-powered positioning device, manufactured without the use of latex, intended to be used on a daily treatment basis to position and stabilize the brachytherapy radiation delivery applicator within the vagina or rectum during brachytherapy radiation therapy procedures, x-ray, or computed tomography (CT) exam. The placement of the balloon device requires a physician or physician directed healthcare professional.

Source page: https://510kreport.com/device/K120344
Methodology: https://510kreport.com/methodology