510(k) Report

FDA applicant

Vasamedics, LLC

Saint Paul, MN6 decisions1991–19970 recalls

FDA records 6 decisions for Vasamedics, LLC (Saint Paul, MN) from 1991 to 1997: 6 510(k) clearances. Most are in product codes DPT (Probe, Blood-Flow, Extravascular) and DPW (Flowmeter, Blood, Cardiovascular). Its devices cite 4 predicates, 3 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 Vasamedics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vasamedics, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Vasamedics, 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?

  • DPTProbe, Blood-Flow, Extravascular3decisions
  • DPWFlowmeter, Blood, Cardiovascular3decisions

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 3 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.

  • K951832Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433Vasamedics, LLC · 19963cite it
  • K951486Model PV2000 Vascular MicrolaboratoryVasamedics, LLC · 19952cite it
  • K961368Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 19962cite it
  • K962700Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring Probe KitVasamedics, LLC · 19971cites it
  • K912446Modif. Laserflo Blood Perfusion Monitor Model BPM2Vasamedics, LLC · 19911cites it

What has FDA decided for it lately?

  • K962700Ventricular Catheter Blood Flow Monitoring Probe Kit and Ventraflo Blood Flow Monitoring Probe KitVasamedics, LLC · 1997
  • K961368Trimflo Parenchymal Blood Flow Monitoring Probe KitVasamedics, LLC · 1996
  • K951832Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433Vasamedics, LLC · 1996
  • K951486Model PV2000 Vascular MicrolaboratoryVasamedics, LLC · 1995
  • K912446Modif. Laserflo Blood Perfusion Monitor Model BPM2Vasamedics, LLC · 1991
  • K911763Laserflo (R) Blood Perfusion Monitor (Model BPM2)Vasamedics, LLC · 1991

All 6 as Vasamedics, LLC →