# DEN130036: Prostate Immobilizer Rectal Balloon

- Pathway: De Novo (Direct)
- Applicant: Radiadyne
- Decided: Jan 28, 2014 after 197 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
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K141154: Oartrac System (2014), 3 descendants of its own
- K150719: OARtrac System with Skin Sensors (2015), 2 descendants of its own
- K162954: OARtrac System with Patient Specific Reusable Universal PSD Sensors (2017), 1 descendant of its own
- K150234: Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 (2015), 1 descendant of its own
- K223249: Pro-Tx Endorectal Balloon (PROT-25) (2023), 0 descendants of its own

Source page: https://510kreport.com/device/DEN130036
Methodology: https://510kreport.com/methodology