Cleared Special

K260119 - SpaceOAR Vue System (SV-2101)

K260119 is an FDA 510(k) clearance for SpaceOAR Vue System (SV-2101), manufactured by Boston Scientific Corporation. The device is a Class 2 Radiology device with product code OVB cleared through the Special 510(k) pathway after a 27-day FDA review.

K260119 · Boston Scientific Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
27d
Days
Class 2
Risk

K260119 is an FDA 510(k) clearance for the SpaceOAR Vue System (SV-2101). Classified as Hydrogel Spacer (product code OVB), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marborough, US). The FDA issued a Cleared decision on February 10, 2026 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5725 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corporation devices

FDA 510(k) Submission Details - K260119

510(k) Number K260119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2026
Decision Date February 10, 2026
Days to Decision 27 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 107d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

OVB Device Classification - Class 2, Special Controls

Product Code OVB Hydrogel Spacer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5725
Definition The Perirectal Spacer 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 The Perirectal Spacer To Reduce The Radiation Dose Delivered To The Anterior Rectum. The Perirectal Spacer 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OVB Hydrogel Spacer

Devices cleared under the same product code (OVB) and FDA review panel - the closest regulatory comparables to K260119.
BioProtect Balloon Implant™ System
K222972 · Bioprotect, Ltd. · Aug 2023
Barrigel Injectable Gel
K220641 · Palette Life Sciences · May 2022
SpaceOAR System
K202224 · Boston Scientific Corporation · Aug 2020
SpaceOAR Vue Hydrogel
K182971 · Augmenix, Inc. · Jul 2019
SpaceOAR System
K181465 · Augmenix, Inc. · Jun 2018
SpaceOAR System
DEN140030 · Augmenix, Inc. · Apr 2015