510(k) Report

FDA applicant

Carolina Medical Electronics

King, NC11 decisions1977–19910 recalls

FDA records 11 decisions for Carolina Medical Electronics (King, NC) from 1977 to 1991: 11 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and DPW (Flowmeter, Blood, Cardiovascular). 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 Carolina Medical Electronics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Carolina Medical Electronics since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Carolina Medical Electronics 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?

  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic3decisions
  • DPWFlowmeter, Blood, Cardiovascular2decisions
  • DWJSystem, Thermal Regulating1decision
  • DXKEchocardiograph1decision
  • IZOGenerator, High-Voltage, X-Ray, Diagnostic1decision
  • DSBPlethysmograph, Impedance1decision

Also: DXY (1).

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.

  • K874685Trans-Scan 3-D Transcranial DopplerCarolina Medical Electronics · 19881cites it
  • K874684TC2-64B Transcranial DopplerCarolina Medical Electronics · 19881cites it

What has FDA decided for it lately?

  • K914200Vascumap Medical Air PlethysmographCarolina Medical Electronics · 1991
  • K874685Trans-Scan 3-D Transcranial DopplerCarolina Medical Electronics · 1988
  • K874684TC2-64B Transcranial DopplerCarolina Medical Electronics · 1988
  • K864624Probe, Uptake, NuclearCarolina Medical Electronics · 1987
  • K843891Dopscan Plus DS1060Carolina Medical Electronics · 1985
  • K837329Sonacolor CD, Model 6300 Cardiac Doppler UltrasoundCarolina Medical Electronics · 1983
  • K820272Cliniflow II, #701, Electromagn. BLD. SYCarolina Medical Electronics · 1982
  • K810561Dopscan Model 1050Carolina Medical Electronics · 1981

All 11 as Carolina Medical Electronics →