510(k) Report

FDA applicant

PathAI, Inc.

Boston, MA2 decisions2022–20250 recalls

FDA records 2 decisions for PathAI, Inc. (Boston, MA) from 2022 to 2025: 2 510(k) clearances. All are in product code QKQ (Digital Pathology Image Viewing And Management…). Its devices cite 3 predicates, 0 of them its own earlier devices. 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 PathAI, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12025: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — PathAI, Inc. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QKQDigital Pathology Image Viewing And Management Software2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

All 2 as PathAI, Inc. →