510(k) Report

FDA applicant

General Devices

Ridgefield, NJ13 decisions1983–20020 recalls

FDA records 13 decisions for General Devices (Ridgefield, NJ) from 1983 to 2002: 13 510(k) clearances. Most are in product codes DRG (Transmitters And Receivers, Physiological…) and GZO (Device, Galvanic Skin Response Measurement). Its devices cite 2 predicates, 2 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for General Devices since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like General Devices’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?

  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency5decisions
  • GZODevice, Galvanic Skin Response Measurement1decision
  • KRCTester, Electrode, Surface, Electrocardiographic1decision
  • DXHTransmitters And Receivers, Electrocardiograph, Telephone1decision
  • DSHRecorder, Magnetic Tape, Medical1decision
  • DXJDisplay, Cathode-Ray Tube, Medical1decision

Also: DRT (1), GYA (1), DSF (1).

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K002089Rosetta-LT/Rosetta-RXGeneral Devices · 20002cite it
  • K896153Modified DR-2C/PMC 100General Devices · 19901cites it

What has FDA decided for it lately?

  • K013533Ems Telemedicine Option (for Gems Series 4000)General Devices · 2002
  • K002089Rosetta-LT/Rosetta-RXGeneral Devices · 2000
  • K993202Eim-107 Prep-CheckGeneral Devices · 1999
  • K940009Gemscom Series 6000, Models 6100, 6200 & 6300General Devices · 1995
  • K935839Gemscom Series 5000,General Devices · 1994
  • K921929Gemscom Series 300 12-Lead Ecg (12-Lead Option)General Devices · 1992
  • K914889Gemscom Series 3000General Devices · 1992
  • K912008Tru-View Multi-Channel DisplayGeneral Devices · 1991

All 13 as General Devices →