510(k) Report

FDA applicant

R2 Corp.

Mchenry, IL9 decisions1980–19830 recalls

FDA records 9 decisions for R2 Corp. (Mchenry, IL) from 1980 to 1983: 9 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and LDD (Dc-Defibrillator, Low-Energy, (Including…). 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, cardiovascular panel, where it files most

How often FDA has decided R2 Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for R2 Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like R2 Corp.’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, Electrocardiograph3decisions
  • LDDDc-Defibrillator, Low-Energy, (Including Paddles)2decisions
  • DSACable, Transducer And Electrode, Patient, (Including Connector)2decisions
  • JOTElectrode, Gel, Electrosurgical1decision
  • IKDCable, Electrode1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K800937R2 Plate Type Cable-Adaptor #S 175,176R2 Corp. · 19801cites it

What has FDA decided for it lately?

  • K832516Magnatrode Cardiac Monitoring ElectrodeR2 Corp. · 1983
  • K800936R2 Paddle Type Cable-Adaptor #S 170,171R2 Corp. · 1980
  • K800930R2(TM) Ecg Electrode Set-#'S305-306 Etc.R2 Corp. · 1980
  • K800932Ecg-RF-Choke Cable-Adapter #'S 121,120R2 Corp. · 1980
  • K800937R2 Plate Type Cable-Adaptor #S 175,176R2 Corp. · 1980
  • K800935R2 Apex-Post.,Ant.&Post. Elect.(12 Mods)R2 Corp. · 1980
  • K800931R2(TM) Ecg Cable-Adaptor #'S 120-121-122R2 Corp. · 1980
  • K800933R2 Electrosurg. Return Elect. #225ETC.R2 Corp. · 1980

All 9 as R2 Corp. →