510(k) · Cleared
Recalled · Class II · 2022SpaceOAR Vue Hydrogel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Augmenix, Inc. · OVB Hydrogel Spacer
Cleared on Jul 19, 2019 as substantially equivalent to DEN140030 (Augmenix, Inc., 2015) and 1 other predicate after a 266-day review. Its family tree reaches back 2 generations to 2015. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 19, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- OVB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN140030 (2015). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN140030 SpaceOAR SystemAugmenix, Inc. · 2015
- 1 generation backK181465 SpaceOAR SystemAugmenix, Inc. · 2018 · Recalled
- This deviceK182971 SpaceOAR Vue HydrogelAugmenix, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK262151 SpaceOAR Flex™ SystemBoston Scientific Corporation · 2026
- Descendant · cites it directly · 0 of its ownK260119 SpaceOAR Vue System (SV-2101)Boston Scientific Corporation · 2026
Most influential descendants
Showing 2 of 2 · See allView 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) | K182971 | SpaceOAR Vue Hydrogel | Augmenix, Inc. | 2019 | — |
| +1 | K262151 | SpaceOAR Flex™ System | Boston Scientific Corporation | 2026 | — |
| +1 | K260119 | SpaceOAR Vue System (SV-2101) | Boston Scientific Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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…ice Product Code: OVB Device Review Panel: Radiology III. PREDICATE DEVICE Predicate Device Trade Name: SpaceOAR® Hydrogel System Cleared for Marketing Under: DEN140030 and K181465. Reference device: TraceIT® Tissue Marker K151998 and K121964. IV. DEVICE DESCRIPTION The SpaceOAR Vue Hydroge… | 2015 |
| * | K181465 | SpaceOAR SystemSummary page 4…de: OVB Device Review Panel: Radiology III. PREDICATE DEVICE Predicate Device Trade Name: SpaceOAR® Hydrogel System Cleared for Marketing Under: DEN140030 and K181465. Reference device: TraceIT® Tissue Marker K151998 and K121964. IV. DEVICE DESCRIPTION The SpaceOAR Vue Hydrogel consists o… | 2018 |
| † | K151998 | TraceIT Tissue Marker - 3mL | 2015 |
| † | K121964 | Markit Tissue Marker-1ML Markit Tissue Marker-3ML Markit Tissue Marker-10ML | 2013 |
What descends from it? (2)
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-1003-2022 | 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 4 years and passes through 1 company; 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, K262151 (Boston Scientific Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 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. 2019, 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 Vue Hydrogel 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 Vue Hydrogel to reduce the radiation dose delivered to the anterior rectum. The SpaceOAR Vue Hydrogel is composed of biodegradable material and maintain 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/K182971 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182971: SpaceOAR Vue Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182971
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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