510(k) Report

FDA applicant

Cardiomedics, Inc.

Irvine, CA5 decisions1987–20051 recall

FDA records 5 decisions for Cardiomedics, Inc. (Irvine, CA) from 1987 to 2005: 5 510(k) clearances. All are in product code DRN (Device, Counter-Pulsating, External). Its devices cite 6 predicates, 3 of them its own earlier devices. 1 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 Cardiomedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardiomedics, Inc. since 2007.

Recalls per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cardiomedics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DRNDevice, Counter-Pulsating, External5decisions

Whose devices does it build on?

Its devices cite 6 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K022107Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 20022cite it
  • K010261Cardiomedics Ecp SystemCardiomedics, Inc. · 20011cites it
  • K023427Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 20031cites it

What has FDA decided for it lately?

  • K050172Cardiassist Counter Pulsation System Series 4000/5000Cardiomedics, Inc. · 20051 recall
  • K023427Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2003
  • K022107Cardiassist Counterpulsation System, Model Mark 3000Cardiomedics, Inc. · 2002
  • K010261Cardiomedics Ecp SystemCardiomedics, Inc. · 2001
  • K872034Cardiomedics External Counterpulsation SystemCardiomedics, Inc. · 1987

All 5 as Cardiomedics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K050172Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device…Apr 9, 2009