510(k) Report

FDA applicant

Vios Medical, Inc.

St. Paul, MN3 decisions2015–20184 recalls

FDA records 3 decisions for Vios Medical, Inc. (St. Paul, MN) from 2015 to 2018: 3 510(k) clearances. Most are in product codes DRT (Monitor, Cardiac (Incl. Cardiotachometer &…) and DXJ (Display, Cathode-Ray Tube, Medical). Its devices cite 6 predicates, 1 of them its own earlier devices. 4 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 Vios Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2015: 12018: 2
2015high 2 (2018) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

2in 2024

2021: 12023: 12024: 2
2015high 2 (2024) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Vios Medical, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vios 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?

  • DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)2decisions
  • DXJDisplay, Cathode-Ray Tube, Medical1decision

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K150992Vios Monitoring SystemVios Medical, Inc. · 20153cite it
  • K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc. · 20182cite it
  • K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. · 20182cite it

What has FDA decided for it lately?

  • K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc. · 2018
  • K172586Vios Monitoring System™ Model 2050Vios Medical, Inc. · 20184 recalls
  • K150992Vios Monitoring SystemVios Medical, Inc. · 2015

All 3 as Vios Medical, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K172586Vios Monitoring System Bedside Monitor Model BSM2050Aug 9, 2024Class II
  • K172586muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including…Apr 22, 2024Class II
  • K172586Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20…Jun 6, 2023Class II
  • K172586muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including…Jun 21, 2021Class II