De Novo · Granted
GrantedSpaceOAR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augmenix, Inc. · OVB Hydrogel Spacer
Granted on Apr 1, 2015 as a new device type through De Novo after a 182-day review. 7 later devices descend from it.
- Decided
- Apr 1, 2015
- Review
- 182 days
- Class
- Class II
- Product code
- OVB
- Recalls
- None
7 later devices descend from it, 3 citing it directly.
- This deviceDEN140030 SpaceOAR SystemAugmenix, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK181465 SpaceOAR SystemAugmenix, Inc. · 2018 · Recalled
- Descendant · cites it directly · 2 of its ownK182971 SpaceOAR Vue HydrogelAugmenix, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK202224 SpaceOAR SystemBoston Scientific Corporation · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK262151 SpaceOAR Flex™ SystemBoston Scientific Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK260119 SpaceOAR Vue System (SV-2101)Boston Scientific Corporation · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K181465SpaceOAR SystemAugmenix, Inc. · 2018 · cites it directly5descendants
- K182971SpaceOAR Vue HydrogelAugmenix, Inc. · 2019 · cites it directly2descendants
- K202224SpaceOAR SystemBoston Scientific Corporation · 2020 · 2 generations on1descendant
- K262151SpaceOAR Flex™ SystemBoston Scientific Corporation · 2026 · 2 generations on0descendants
- K260119SpaceOAR Vue System (SV-2101)Boston Scientific Corporation · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN140030 | SpaceOAR System | Augmenix, Inc. | 2015 | — |
| +1 | K181465 | SpaceOAR System | Augmenix, Inc. | 2018 | 1 |
| +1 | K182971 | SpaceOAR Vue Hydrogel | Augmenix, Inc. | 2019 | 1 |
| +2 | K202224 | SpaceOAR System | Boston Scientific Corporation | 2020 | 1 |
| +2 | K262151 | SpaceOAR Flex™ System | Boston Scientific Corporation | 2026 | — |
| +2 | K260119 | SpaceOAR Vue System (SV-2101) | Boston Scientific Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K181465 (Augmenix, Inc., 2018) has gone furthest, with 5 descendants of its own.
How does its category compare?
All OVB devicesOVB Hydrogel Spacer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
SpaceOAR 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 SpaceOAR System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR System is composed of biodegradable material and maintains 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/DEN140030 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN140030: SpaceOAR System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN140030
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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