Cleared Traditional

K254115 - ArteraAI Breast

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

FDA 510(k) Submission Details - K254115

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.

SHW Device Classification - Class ,

Product Code SHW
Device Class -