510(k) Report

FDA applicant

Carolina Medical, Inc.

King, NC2 decisions2000–20050 recalls

FDA records 2 decisions for Carolina Medical, Inc. (King, NC) from 2000 to 2005: 2 510(k) clearances. Most are in product codes FRN (Pump, Infusion) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 2 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, general hospital panel, where it files most

How often FDA has decided Carolina Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Carolina Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Carolina Medical, 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?

  • FRNPump, Infusion1decision
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K050324Infpump Infiltration PumpCarolina Medical, Inc. · 2005
  • K993978PR3 Ultrasound SystemCarolina Medical, Inc. · 2000

All 2 as Carolina Medical, Inc. →