510(k) · Cleared
ClearedVirtus Metabolic Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Virtus Technology Aps · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Jun 23, 2023 as substantially equivalent to K190800 (Cosmed Srl, 2020) after a 268-day review. Its family tree reaches back 2 generations to 2012.
- Decided
- Jun 23, 2023
- Review
- 268 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K120146 (2012). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BTY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BTY device
- #1 K260242 CPETWise Platformscore 13.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsSummary page 4…Class II Predicate Device Substantial Equivalence to: 510(K) Number Model Manufacturer K190800 Cosmed Q-NRG+ Cosmed Srl Portable Metabolic Vi dei Piani… | 2020 |
| † | K051092 | Datex-Ohmeda S/5 Compact Airway Module (Model Family E-Caiovx) E-Caiovx, E-Caiov… | 2005 |
| † | K093080 | Metaphor Metabolic Monitor | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 7.2 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All BTY devicesBTY Calculator, Predicted Values, Pulmonary Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · BTY
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BTY
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTY
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTY
5in 2024
MAUDE reports naming product code BTY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 3 | 104 | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 3 | 139 | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 24 |
| 2017 | 1 | — | 2 | 9 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 3 | 266 | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Virtus Metabolic Monitor is indicated for the measurement of Resting Energy Expenditure (REE) for mechanically ventilated patients, who are non-spontaneous breathing, and who are at least 18 years of age.
The Virtus Metabolic Monitor is intended to be used in Intensive Care Units (ICUs) in professional healthcare facilities only.
The Virtus Metabolic Monitor is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222982 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222982: Virtus Metabolic Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222982
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026