510(k) Report

FDA applicant

R2 Medical Systems

Niles, IL1 decision1994–19941 recall

FDA records 1 decision for R2 Medical Systems (Niles, IL) in 1994: 1 510(k) clearance. All are in product code 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 R2 Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for R2 Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — R2 Medical Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like R2 Medical Systems’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?

  • DRXElectrode, Electrocardiograph1decision

What has FDA decided for it lately?

  • K935371R2 Pads, R2 Cath Pads, R2 Pace Pads, R2 Dispersive PadR2 Medical Systems · 19941 recall

The one decision as R2 Medical Systems →

What has been recalled?

1 recall linked to its devices; the latest:

  • K935371Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent multifunction…May 18, 2006