# K223249: Pro-Tx Endorectal Balloon (PROT-25)

- Pathway: 510(k) (Abbreviated)
- Applicant: Dxtx Medical, Inc.
- Decided: Feb 10, 2023 after 151 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.
No later device cites it as a predicate yet.
0 of 2 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. Summary page 4.

## Indications for use
The DxTx Medical Pro-Tx Endorectal Balloon is a disposable, single use non-powered inflatable positioning device intended to be used for temporary positioning of the rectal wall and adjacent structures in the male human anatomies and to assist in positioning the prostate in a more predictable and reproducible location. The purpose of the DxTx Medical Pro-Tx Endorectal Balloon is to stabilize the rectal wall and surrounding anatomy during all phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery. Only trained healthcare professionals are intended to operate this device.

Source page: https://510kreport.com/device/K223249
Methodology: https://510kreport.com/methodology