510(k) Report

FDA applicant

R & D Medical Products, Inc.

Lake Forest, CA4 decisions1998–20110 recalls

FDA records 4 decisions for R & D Medical Products, Inc. (Lake Forest, CA) from 1998 to 2011: 4 510(k) clearances. Most are in product codes DRX (Electrode, Electrocardiograph) and GWJ (Stimulator, Auditory, Evoked Response). Its devices cite 3 predicates, 0 of them its own earlier devices. 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, neurology panel, where it files most

How often FDA has decided R & D Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2009: 12011: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like R & D 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.

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Which product codes does it file in?

  • DRXElectrode, Electrocardiograph1decision
  • GWJStimulator, Auditory, Evoked Response1decision
  • KGZAccessories, Catheter1decision
  • GXYElectrode, Cutaneous1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K092744Neonatal Ecg Electrode, M203KENR & D Medical Products, Inc. · 20092cite it

What has FDA decided for it lately?

  • K111555Circumaural Adhesive ReplacementR & D Medical Products, Inc. · 2011
  • K092744Neonatal Ecg Electrode, M203KENR & D Medical Products, Inc. · 2009
  • K001117Comfort StimR & D Medical Products, Inc. · 2000
  • K973183Wound Drainage HolderR & D Medical Products, Inc. · 1998

All 4 as R & D Medical Products, Inc. →