510(k) Report

FDA applicant

Viterion Telehealthcare, LLC

Tarrytown, NY1 decision2003–20032 recalls

FDA records 1 decision for Viterion Telehealthcare, LLC (Tarrytown, NY) in 2003: 1 510(k) clearance. All are in product code MWI (Monitor, Physiological, Patient (Without…). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are 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 Viterion Telehealthcare, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Viterion Telehealthcare, LLC since 2007.

Recalls per year

2in 2012

2012: 2
2007high 2 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Viterion Telehealthcare, 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?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision

Whose devices does it build on?

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

Who builds on its devices?

Later devices cite its devices 5 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.

  • K030419Viterion 100 Telehealth MonitorViterion Telehealthcare, LLC · 20035cite it

What has FDA decided for it lately?

  • K030419Viterion 100 Telehealth MonitorViterion Telehealthcare, LLC · 20032 recalls

The one decision as Viterion Telehealthcare, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K030419Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) --…Nov 15, 2012Class II
  • K030419Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218…Nov 15, 2012Class II