# K092534: Alatus Vaginal Balloon Packing System

- Pathway: 510(k) (Traditional)
- Applicant: Radiadyne
- Decided: Dec 7, 2009 after 110 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 K001544 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001544: Vaginal Applicator Shielded, Mick Radio-Nuclear Instruments, Inc. (2000)
- K002912: Vaginal Port, Non-Sterile / 600065, Vaginal Port, Sterile / 600073, Sterinc (2001) Summary page 3.

## Most influential descendants
- K120344: Radiapak Brachytherapy Applicator Balloon Device (2012), 0 descendants of its own

## Indications for use
The ALATUS Vaginal Balloon Packing System is a single use, non-sterile, disposable, flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.

Source page: https://510kreport.com/device/K092534
Methodology: https://510kreport.com/methodology