510(k) Report

FDA applicant

Analytics For Life, Inc.

Toronto, CA2 decisions2024–20260 recalls

FDA records 2 decisions for Analytics For Life, Inc. (Toronto, CA) from 2024 to 2026: 2 510(k) clearances. Most are in product codes SAT (Pulmonary Hypertension Machine Learning-Based…) and DQK (Computer, Diagnostic, Programmable). Its devices cite 2 predicates, 1 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2024

2024: 12026 (partial year): 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Analytics For Life, Inc. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Analytics For Life, 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?

  • SATPulmonary Hypertension Machine Learning-Based Notification Software1decision
  • DQKComputer, Diagnostic, Programmable1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K233666CorVista System with PH Add-OnAnalytics For Life, Inc. · 20242cite it

What has FDA decided for it lately?

  • K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc. · 2026
  • K233666CorVista System with PH Add-OnAnalytics For Life, Inc. · 2024

All 2 as Analytics For Life, Inc. →