510(k) Report

FDA applicant

Crs Medical Diagnostics, Inc.

Deer Field, IL2 decisions2005–20070 recalls

FDA records 2 decisions for Crs Medical Diagnostics, Inc. (Deer Field, IL) from 2005 to 2007: 2 510(k) clearances. All are in product code LJS (Catheter, Intravascular, Therapeutic…). Its devices cite 3 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Crs Medical Diagnostics, Inc. 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?

  • LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K050889Fibrin Analysis System Endoluminal BrushCrs Medical Diagnostics, Inc. · 20051cites it

What has FDA decided for it lately?

  • K072518CRS Fibrin Analysis Catheter Testing System (Facts)Crs Medical Diagnostics, Inc. · 2007
  • K050889Fibrin Analysis System Endoluminal BrushCrs Medical Diagnostics, Inc. · 2005

All 2 as Crs Medical Diagnostics, Inc. →