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
Boston Scientific Corporation · OVB Hydrogel Spacer
Cleared on Aug 28, 2020 as substantially equivalent to K181465 (Augmenix, Inc., 2018) after a 21-day review. Its family tree reaches back 2 generations to 2015. 1 later device descends from it. It has been recalled once.
- Decided
- Aug 28, 2020
- Review
- 21 days
- Class
- Class II
- Product code
- OVB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN140030 (2015). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN140030 SpaceOAR SystemAugmenix, Inc. · 2015
- 1 generation backK181465 SpaceOAR SystemAugmenix, Inc. · 2018 · Recalled
- This deviceK202224 SpaceOAR SystemBoston Scientific Corporation · 2020
- Descendant · cites it directly · 0 of its ownK220641 Barrigel Injectable GelPalette Life Sciences · 2022
Most influential descendants
Showing 1 of 1 · See all- K220641Barrigel Injectable GelPalette Life Sciences · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN140030 | SpaceOAR System | Augmenix, Inc. | 2015 | — |
| −1 | K181465 | SpaceOAR System | Augmenix, Inc. | 2018 | 1 |
| 0 (this device) | K202224 | SpaceOAR System | Boston Scientific Corporation | 2020 | — |
| +1 | K220641 | Barrigel Injectable Gel | Palette Life Sciences | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 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 |
|---|---|---|---|
| * | K181465 | SpaceOAR SystemSummary page 4…Classification Name: Absorbable Perirectal Spacer Classification: Class II Product Code: OVB Identification of Predicate Device: SpaceOAR Hydrogel System, K181465 E. Device Description The SpaceOAR Hydrogel System consists of components for the preparation of a synthetic, absorbab… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220641 | Barrigel Injectable Gel | 2022 | 0 |
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K220641 (Palette Life Sciences, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181465.
How does its category compare?
All OVB devicesOVB Hydrogel Spacer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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/K202224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202224: 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/K202224
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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