510(k) Report

FDA applicant

Assurance Medical

Washington, DC1 decision2003–20030 recalls

FDA records 1 decision for Assurance Medical (Washington, DC) in 2003: 1 De Novo grant. All are in product code NKA (System, Documentation, Breast Lesion). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Assurance Medical since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Assurance Medical by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NKASystem, Documentation, Breast Lesion1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • DEN020001Breastview Visual Mapping SystemAssurance Medical · 20032cite it

What has FDA decided for it lately?

  • DEN020001Breastview Visual Mapping SystemAssurance Medical · 2003

The one decision as Assurance Medical →