Cleared Traditional

K262151 - SpaceOAR Flex™ System

K262151 is an FDA 510(k) clearance for SpaceOAR Flex System, manufactured by Boston Scientific Corporation. The device is a Class 2 Radiology device with product code OVB cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K262151 · Boston Scientific Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
78d
Days
Class 2
Risk

K262151 is an FDA 510(k) clearance for the SpaceOAR Flex™ System. Classified as Hydrogel Spacer (product code OVB), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Marlborough, US). The FDA issued a Cleared decision on September 11, 2026 after a review of 78 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corporation devices

FDA 510(k) Submission Details - K262151

510(k) Number K262151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2026
Decision Date September 11, 2026
Days to Decision 78 days
Submission Type Traditional
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
29d faster than avg
Panel avg: 107d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Radiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06451614 Active not recruiting Interventional Industry-sponsored

SpaceIT Hydrogel System for Perirectal Spacing

SpaceIT Hydrogel System for Perirectal Spacing in Subjects With Low to Intermediate Risk Prostate Cancer Undergoing External Beam Radiotherapy (EBRT)

230
Patients (est.)
26
Sites
Treatment
Purpose
Open label
Masking
Condition studied Prostate Cancer
Study design Parallel
Eligibility Male only · 18 Years+
Principal investigator Brian Baumann, MD
Sponsor Boston Scientific Corporation (industry)
Started 2024-10-30 → Primary completion 2026-09-30 → Completed 2028-03-31
Primary outcome
Primary Safety Endpoint - Acute Grade 3 or greater adverse events.
Secondary outcome
Additional Safety Endpoint - Adverse Device Effects (ADEs) requiring additional procedures and/or medications
View full study on ClinicalTrials.gov

Regulatory Peers - OVB Hydrogel Spacer

All 7
Devices cleared under the same product code (OVB) and FDA review panel - the closest regulatory comparables to K262151.
SpaceOAR Vue System (SV-2101)
K260119 · Boston Scientific Corporation · Feb 2026
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