510(k) Report

FDA applicant

Cardio Surgical Concepts, Inc.

Mchenry, IL1 decision1980–19800 recalls

FDA records 1 decision for Cardio Surgical Concepts, Inc. (Mchenry, IL) in 1980: 1 510(k) clearance. All are in product code JCX (Apparatus, Suction, Ward Use, Portable…). 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 and plastic surgery panel, where it files most

How often FDA has decided Cardio Surgical Concepts, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardio Surgical Concepts, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Cardio Surgical Concepts, 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?

  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K801043E-Vax Chest Drainage SystemCardio Surgical Concepts, Inc. · 19803cite it

What has FDA decided for it lately?

  • K801043E-Vax Chest Drainage SystemCardio Surgical Concepts, Inc. · 1980

The one decision as Cardio Surgical Concepts, Inc. →