Cleared Traditional

ArteraAI Breast (K254115) - FDA 510(k) Clearance

K254115 · Artera, Inc. · Pathology device
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May 2026
Decision
136d
Days
-
Risk

K254115 is an FDA 510(k) clearance for the ArteraAI Breast.

Submitted by Artera, Inc. (Los Altos, US). The FDA issued a Cleared decision on May 4, 2026 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Artera, Inc. devices

Submission Details

510(k) Number K254115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2025
Decision Date May 04, 2026
Days to Decision 136 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 77d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code SHW
Device Class -