# K180478: RectalPro 75 Endorectal Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Qlrad International, Ltd.
- Decided: Nov 13, 2018 after 264 days
- Product code: PCT (Prostate Immobilizer Rectal Balloon)
- Device class: 2
- Regulation: 21 CFR 892.5720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN130036 (2014). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150234: Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301, Myriad Medical, LLC (2015) Summary page 5.

## Indications for use
The RectalPro™75 Endorectal Balloon device is a single-use disposable, inflatable, non-powered positioning device intended for us in the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose of the device is to stabilize the prostate during Computed Tomography (CT) exam, and X-Ray when these imaging techniques are used for Radiation Therapy (RT) planning.

Source page: https://510kreport.com/device/K180478
Methodology: https://510kreport.com/methodology