# K141958: Erb Endorectal Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Edge Medical, LLC
- Decided: Nov 18, 2014 after 123 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.

## Indications for use
The ERB is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery.

Source page: https://510kreport.com/device/K141958
Methodology: https://510kreport.com/methodology