# K150234: Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301

- Pathway: 510(k) (Traditional)
- Applicant: Myriad Medical, LLC
- Decided: Mar 31, 2015 after 57 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: 1 generation back to DEN130036 (2014). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN130036: Prostate Immobilizer Rectal Balloon, Radiadyne (2014). Our reading of the summary gave K132194, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130036, Prostate Immobilizer Rectal Balloon (Radiadyne), granted Jan 28, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K180478: RectalPro 75 Endorectal Balloon (2018), 0 descendants of its own

## Indications for use
The Myriad Prostate Caddy™ Immobilization Rectal Balloon is a single-use disposable, inflatable, non-powered positioning device intended for use 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. The placement of the balloon requires a Physician or a Physician directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.

Source page: https://510kreport.com/device/K150234
Methodology: https://510kreport.com/methodology