510(k) · Cleared
Recalled · Class II · 2022SpaceOAR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augmenix, Inc. · OVB Hydrogel Spacer
Cleared on Jun 25, 2018 as substantially equivalent to DEN140030 (Augmenix, Inc., 2015) after a 21-day review. Its family tree reaches back 1 generation to 2015. 5 later devices descend from it. It has been recalled once.
- Decided
- Jun 25, 2018
- Review
- 21 days
- Class
- Class II
- Product code
- OVB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN140030 (2015). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN140030 SpaceOAR SystemAugmenix, Inc. · 2015
- This deviceK181465 SpaceOAR SystemAugmenix, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK182971 SpaceOAR Vue HydrogelAugmenix, Inc. · 2019 · Recalled
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 0 of its ownK220641 Barrigel Injectable GelPalette Life Sciences · 2022
Most influential descendants
Showing 5 of 5 · See all- K182971SpaceOAR Vue HydrogelAugmenix, Inc. · 2019 · cites it directly2descendants
- K202224SpaceOAR SystemBoston Scientific Corporation · 2020 · cites it directly1descendant
- K262151SpaceOAR Flex™ SystemBoston Scientific Corporation · 2026 · 2 generations on0descendants
- K260119SpaceOAR Vue System (SV-2101)Boston Scientific Corporation · 2026 · 2 generations on0descendants
- K220641Barrigel Injectable GelPalette Life Sciences · 2022 · 2 generations on0descendants
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) | K181465 | SpaceOAR System | Augmenix, Inc. | 2018 | — |
| +1 | K182971 | SpaceOAR Vue Hydrogel | Augmenix, Inc. | 2019 | 1 |
| +1 | 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 | — |
| +2 | K220641 | Barrigel Injectable Gel | Palette Life Sciences | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 2 | 0 |
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…ss || Device Product Code: OVB Device Review Panel: Radiology n. PREDICATE DEVICE Predicate Device Trade Name: SpaceOAR® Hydroge! System Cleared for Marketing Under: DEN140030. This predicate has not been subject to a design-related recall. No reference devices were used in this submission. V. DEVICE… | 2015 |
What descends from it? (5)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 24, 2022 | Class II | Z-1002-2022 | Labeling design | Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All OVB devicesOVB Hydrogel Spacer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Hydrogel 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 Hydrogel System to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Hydrogel 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181465: SpaceOAR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181465
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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