510(k) Report

FDA applicant

Artera, Inc.

Los Altos, CA2 decisions2025–20260 recalls

FDA records 2 decisions for Artera, Inc. (Los Altos, CA) from 2025 to 2026: 1 510(k) clearance and 1 De Novo grant. Most are in product codes SFH (Pathology Software Algorithm Device Analyzing…) and SHW (Pathology Software Algorithm Device Analyzing…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, pathology panel, where it files most

How often FDA has decided Artera, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 12026 (partial year): 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Artera, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Artera, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • SFHPathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis1decision
  • SHWPathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K254115ArteraAI BreastArtera, Inc. · 20261cites it

What has FDA decided for it lately?

  • K254115ArteraAI BreastArtera, Inc. · 2026
  • DEN240068ArteraAI ProstateArtera, Inc. · 2025

All 2 as Artera, Inc. →