510(k) Report

FDA applicant

Vasc-Alert, LLC

Chicago, IL2 decisions2003–20040 recalls

FDA records 2 decisions for Vasc-Alert, LLC (Chicago, IL) from 2003 to 2004: 2 510(k) clearances. Most are in product codes KOC (Accessories, Blood Circuit, Hemodialysis) and MQS (System, Hemodialysis, Access Recirculation…). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Vasc-Alert, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Vasc-Alert, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vasc-Alert, 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?

  • KOCAccessories, Blood Circuit, Hemodialysis1decision
  • MQSSystem, Hemodialysis, Access Recirculation Monitoring1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K030456Vasc-AlertVasc-Alert, LLC · 20031cites it
  • K042566Vasc-AlertVasc-Alert, Inc. · 20041cites it

What has FDA decided for it lately?

  • K042566Vasc-AlertVasc-Alert, Inc. · 2004
  • K030456Vasc-AlertVasc-Alert, LLC · 2003

The one decision as Vasc-Alert, LLC →The one decision as Vasc-Alert, Inc. →