510(k) Report

FDA applicant

New Dimensions IN Medicine, Inc.

Mchenry, IL6 decisions1977–19920 recalls

FDA records 6 decisions for New Dimensions IN Medicine, Inc. (Mchenry, IL) from 1977 to 1992: 6 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and NAE (Dressing, Wound, Hydrogel Without Drug And/Or…). 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 New Dimensions IN Medicine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for New Dimensions IN Medicine, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — New Dimensions IN Medicine, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GXYElectrode, Cutaneous1decision
  • NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic1decision
  • JOSElectrode, Electrosurgical1decision
  • EHEDispenser, Mercury And/Or Alloy1decision
  • FLSMonitor, Apnea, Facility Use1decision
  • GYBMedia, Electroconductive1decision

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.

  • K920677Clearsite Hydrogel Wound Dressing ModificationNew Dimensions IN Medicine, Inc. · 19921cites it
  • K822077Respiration Monitor Type MR-10New Dimensions IN Medicine, Inc. · 19821cites it

What has FDA decided for it lately?

  • K920677Clearsite Hydrogel Wound Dressing ModificationNew Dimensions IN Medicine, Inc. · 1992
  • K832145Monoblock Prostoperative Tens ElectrodeNew Dimensions IN Medicine, Inc. · 1983
  • K822077Respiration Monitor Type MR-10New Dimensions IN Medicine, Inc. · 1982
  • K780631NDM Infant Ecg PackpadNew Dimensions IN Medicine, Inc. · 1978
  • K780405Infant Electrosurgical Grounding PadNew Dimensions IN Medicine, Inc. · 1978
  • K771749Amalgam DispenserNew Dimensions IN Medicine, Inc. · 1977

All 6 as New Dimensions IN Medicine, Inc. →