# K222972: BioProtect Balloon Implant™ System

- Pathway: 510(k) (Traditional)
- Applicant: Bioprotect, Ltd.
- Decided: Aug 25, 2023 after 332 days
- Product code: OVB (Hydrogel Spacer)
- Device class: 2
- Regulation: 21 CFR 892.5725
- 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 DEN140030 (2015). 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)
- DEN140030: SpaceOAR System, Augmenix, Inc. (2015) Summary page 4.

## Indications for use
The BioProtect Balloon Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the BioProtect Balloon Implant System to reduce the radiation dose delivered to the anterior rectum. The BioProtect Balloon Implant System is composed of a balloon made of a biodegradable material that maintains the space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient’s body over time.

Source page: https://510kreport.com/device/K222972
Methodology: https://510kreport.com/methodology