Not Cleared Direct

DEN240068 - ArteraAI Prostate

DEN240068 is an FDA 510(k) submission for ArteraAI Prostate, manufactured by Artera, Inc.. The device is a Class 2 Pathology device with product code SFH cleared through the Direct 510(k) pathway after a 248-day FDA review.

DEN240068 · Artera, Inc. · Pathology device
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Jul 2025
Decision
248d
Days
Class 2
Risk

DEN240068 is an FDA 510(k) submission (not cleared) for the ArteraAI Prostate. Classified as Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis (product code SFH), Class II - Special Controls.

Submitted by Artera, Inc. (Los Altos, US). The FDA issued a Not Cleared (DENG) decision on July 31, 2025 after a review of 248 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3755 - the FDA pathology device 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 Pathology review framework.

FDA 510(k) Submission Details - DEN240068

510(k) Number DEN240068 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 25, 2024
Decision Date July 31, 2025
Days to Decision 248 days
Submission Type Direct
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 78d · This submission: 248d
Pathway characteristics

SFH Device Classification - Class 2, Special Controls

Product Code SFH Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.3755
Definition A Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis Is A Software Intended To Analyze Scanned Whole Slide Images (wsis) From Prostate Biopsies Prepared From Formalin Fixed Paraffin-embedded (ffpe) Tissue And Stained Using Hematoxylin & Eosin (h&e) Stains. The Device Provides Prognostic Risk Estimates Which Are Intended To Assist Physicians With Prognostic Risk-based Decisions Along With Other Clinicopathological Factors. The Device Is Not Intended To Determine A Clinical Diagnosis.
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 Pathology devices follow this clearance model.

DEN240068 · ArteraAI Prostate
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