510(k) Report

FDA applicant

Cardio-Med-Associates, Inc.

Billings, MT2 decisions1993–19931 recall

FDA records 2 decisions for Cardio-Med-Associates, Inc. (Billings, MT) in 1993: 2 510(k) clearances. Most are in product codes DWE (Tubing, Pump, Cardiopulmonary Bypass) and FZH (Apparatus, Air Handling, Room). 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 Cardio-Med-Associates, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cardio-Med-Associates, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cardio-Med-Associates, 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?

  • DWETubing, Pump, Cardiopulmonary Bypass1decision
  • FZHApparatus, Air Handling, Room1decision

What has FDA decided for it lately?

  • K923231Cardio-Pak Basic Pump PackCardio-Med-Associates, Inc. · 19931 recall
  • K923233Cardio-Pak Laparotomy PackCardio-Med-Associates, Inc. · 19931 recall

All 2 as Cardio-Med-Associates, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K902475Custom surgical packs for a variety of surgical applications. Each pack is custom…Mar 25, 2003