510(k) Report

FDA applicant

Lumedx

Bellevue, WA2 decisions2012–20120 recalls

FDA records 2 decisions for Lumedx (Bellevue, WA) in 2012: 2 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and DQK (Computer, Diagnostic, Programmable). Its devices cite 4 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, radiology panel, where it files most

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

FDA decisions per year

2in 2012

2012: 2
2012high 2 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Lumedx by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision
  • DQKComputer, Diagnostic, Programmable1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K123466Healthview Ecg ManagerLumedx · 2012
  • K120514CardiopacsLumedx · 2012

All 2 as Lumedx →