510(k) · Cleared
ClearedBioProtect Balloon Implant™ System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioprotect, Ltd. · OVB Hydrogel Spacer
Cleared on Aug 25, 2023 as substantially equivalent to DEN140030 (Augmenix, Inc., 2015) after a 332-day review. Its family tree reaches back 1 generation to 2015.
- Decided
- Aug 25, 2023
- Review
- 332 days
- Class
- Class II
- Product code
- OVB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN140030 (2015). No later device cites it as a predicate yet.
- Root · 1 generation backDEN140030 SpaceOAR SystemAugmenix, Inc. · 2015
- This deviceK222972 BioProtect Balloon Implant™ SystemBioprotect, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN140030 | SpaceOAR System | Augmenix, Inc. | 2015 | — |
| 0 (this device) | K222972 | BioProtect Balloon Implant™ System | Bioprotect, Ltd. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OVB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OVB device
- #1 K262151 SpaceOAR Flex™ Systemscore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN140030 | SpaceOAR SystemSummary page 4…de: OVB Regulatory class: II (Special Controls) Review Panel: Radiology IV. Predicate Device Identification of Predicate Device: SpaceOAR System (DEN140030) Common/Usual Name: Hydrogel Spacer V. Device Description The BioProtect Balloon Implant™ System is composed o… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate DEN140030.
How does its category compare?
All OVB devicesOVB Hydrogel Spacer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OVB
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · OVB
Too few OVB 510(k)s in any year since 2007 to give a median.
Recalls per year · OVB
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVB
339in 2025
MAUDE reports naming product code OVB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 11 |
| 2019 | 1 | — | 0 | 85 |
| 2020 | 1 | — | 0 | 126 |
| 2021 | 0 | — | 0 | 272 |
| 2022 | 1 | — | 2 | 387 |
| 2023 | 1 | — | 0 | 327 |
| 2024 | 0 | — | 0 | 329 |
| 2025 | 0 | — | 0 | 339 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222972 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222972: BioProtect Balloon Implant™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222972
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026