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Virtus Metabolic Monitor

by Virtus Technology ApS EUDAMED510(k)

Active European Union and United States

510(k) K222982

Overview

The Virtus Metabolic Monitor is a Pulmonary Function Calculator designed to measure Resting Energy Expenditure (REE) in mechanically ventilated adult patients. It processes respiratory gas and flow data via a side-stream capture technique, enabling precise metabolic assessments without manual calibration.

The device is supplied as a reusable medical instrument, intended for use in clinical settings such as anesthesia and critical care. It adheres to FDA 510(k) clearance (K222982) and MDR compliance, with no specified sterility requirements. The monitor features easy-to-connect tubes and immediate operational readiness upon setup, requiring only gas and flow inputs for functionality.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK222982 Date23 Jun 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
BTY
Device Class
Class II
Regulation
21 CFR Part 868.1890
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from Virtus Technology ApS

Questions

  • What clinical settings is the Virtus Metabolic Monitor primarily designed for, and how does it differ from manual calibration methods?

    The Virtus Metabolic Monitor is designed for use in anesthesia and critical care environments where mechanically ventilated adult patients require precise Resting Energy Expenditure (REE) measurements. Unlike manual calibration methods, it uses a side-stream capture technique to process respiratory gas and flow data automatically, eliminating the need for manual adjustments and ensuring faster, more consistent metabolic assessments upon setup.

  • Is the Virtus Metabolic Monitor intended for single-use or reusable applications, and what maintenance considerations should be noted?

    The Virtus Metabolic Monitor is reusable, intended for repeated use in clinical settings. Since it is not sterile by design, proper cleaning and maintenance protocols must be followed between uses to ensure accurate performance. The device requires only gas and flow inputs for operation, with no additional calibration steps beyond initial setup.

  • What regulatory pathways does the Virtus Metabolic Monitor follow, and how does this affect its use in healthcare facilities?

    The device follows FDA 510(k) clearance (K222982) and MDR compliance, confirming it meets U.S. and EU regulatory standards for safety and performance. This ensures it can be legally used in facilities adhering to these frameworks, though no specific sterility requirements are stated—facilities must implement their own infection control protocols for reusable instruments.

  • How quickly can the Virtus Metabolic Monitor provide operational readiness after setup, and what inputs does it require?

    The Virtus Metabolic Monitor achieves immediate operational readiness upon setup, requiring only gas and flow inputs to begin processing respiratory data. Its design simplifies connectivity with easy-to-connect tubes, reducing downtime and streamlining workflow in time-sensitive clinical environments like critical care.