510(k) Report

FDA applicant

Classic Medical Products, Inc.

Muskego, WI2 decisions1986–19901 recall

FDA records 2 decisions for Classic Medical Products, Inc. (Muskego, WI) from 1986 to 1990: 2 510(k) clearances. Most are in product codes DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary…) and DRX (Electrode, Electrocardiograph). 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 Classic Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Classic Medical Products, Inc. since 2007.

Recalls per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Classic Medical Products, 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?

  • DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass1decision
  • DRXElectrode, Electrocardiograph1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K900519Classic Ecg/Stimulating NO. 1700 SeriesClassic Medical Products, Inc. · 19902cite it

What has FDA decided for it lately?

  • K900519Classic Ecg/Stimulating NO. 1700 SeriesClassic Medical Products, Inc. · 19901 recall
  • K862953Classic Resting Silver-Silverchloride ElectrodeClassic Medical Products, Inc. · 1986

All 2 as Classic Medical Products, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K900519Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An…Feb 9, 2012Class II

Other applicant names beginning “Classic”

FDA records each applicant name separately; these may or may not be the same firm.

Classic Elegance Intl., Inc. 1Classic Tan, Inc. 1