510(k) · Cleared

Cleared

SpaceOAR Flex™ System

K262151510(k) TraditionalCleared Sep 11, 202678-day reviewClass II21 CFR 892.5725

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corporation · OVB Hydrogel Spacer

Cleared on Sep 11, 2026 as substantially equivalent to K182971 (Augmenix, Inc., 2019) after a 78-day review. Its family tree reaches back 3 generations to 2015.

Decided: Sep 11, 2026
Review: 78 days
Class: Class II
Product code: OVB
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to DEN140030 (2015). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backDEN140030 SpaceOAR SystemAugmenix, Inc. · 2015
2 generations backK181465 SpaceOAR SystemAugmenix, Inc. · 2018 · Recalled
1 generation backK182971 SpaceOAR Vue HydrogelAugmenix, Inc. · 2019 · Recalled
This deviceK262151 SpaceOAR Flex™ SystemBoston Scientific Corporation · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	DEN140030	SpaceOAR System	Augmenix, Inc.	2015	—
−2	K181465	SpaceOAR System	Augmenix, Inc.	2018	1
−1	K182971	SpaceOAR Vue Hydrogel	Augmenix, Inc.	2019	1
0 (this device)	K262151	SpaceOAR Flex™ System	Boston Scientific Corporation	2026	—

FIG. 1 — Lineage of K262151, 2015–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K260119 SpaceOAR Vue System (SV-2101)score 11.4 · 3 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K182971	SpaceOAR Vue Hydrogel Summary page 5 …Product Code OVB 510(k) Submitter/ Holder Boston Scientific Corporation 510(k)# and Clearance Date K182971 cleared on July 19, 2019 Page 1 of 7 E. Device Description…	Augmenix, Inc.	2019	1

Also cleared against K182971: 1 other device →

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?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
2 of the 3 ancestors have a recall of any class.
1 other device also cites its predicate K182971.

How does its category compare?

All OVB devices

OVB Hydrogel Spacer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · OVB

2so far in 2026, the most since 2007

2007high 2 (2026) · low 0 (2007)2026

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

2007high 2 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OVB

339in 2025

2007high 387 (2022) · low 0 (2007)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 Flex 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 Flex System to reduce the

radiation dose delivered to the anterior rectum. The SpaceOAR Flex System is composed of a radiopaque, biodegradable

material that 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/K262151 · printed Nov 6, 2026

Cite this page

510(k) Report. “K262151: SpaceOAR Flex™ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262151

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Record history

FDA decision record loaded Oct 30, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026