Not Cleared Direct

SpaceOAR System (DEN140030) - FDA 510(k) Clearance

Class II Radiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN140030 · Augmenix, Inc. · Radiology device
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Apr 2015
Decision
182d
Days
Class 2
Risk

DEN140030 is an FDA 510(k) submission (not cleared) for the SpaceOAR System. Classified as Hydrogel Spacer (product code OVB), Class II - Special Controls.

Submitted by Augmenix, Inc. (Waltham, US). The FDA issued a Not Cleared (DENG) decision on April 1, 2015 after a review of 182 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Radiology review framework.

View all Augmenix, Inc. devices

Submission Details

510(k) Number DEN140030 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 01, 2014
Decision Date April 01, 2015
Days to Decision 182 days
Submission Type Direct
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 107d · This submission: 182d
Pathway characteristics

Device Classification

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 DEN140030.
SpaceOAR Vue System (SV-2101)
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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