510(k) Report

FDA applicant

Ultralink, LLC

St Petersburg, FL2 decisions2001–20020 recalls

FDA records 2 decisions for Ultralink, LLC (St Petersburg, FL) from 2001 to 2002: 2 510(k) clearances. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 1 predicate, 1 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Ultralink, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ultralink, LLC 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, Ultrasonic2decisions

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K021333ArtemisUltralink, LLC · 20022cite it
  • K003890VHF Ultrasonic Arc-Scan SystemUltralink, LLC · 20011cites it

What has FDA decided for it lately?

  • K021333ArtemisUltralink, LLC · 2002
  • K003890VHF Ultrasonic Arc-Scan SystemUltralink, LLC · 2001

All 2 as Ultralink, LLC →