# K190800: Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Cosmed Srl
- Decided: Feb 6, 2020 after 315 days
- Product code: BTY (Calculator, Predicted Values, Pulmonary Function)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K120146 (2012). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120146: Quark Series, Cosmed Srl (2012) Summary page 6.

## Most influential descendants
- K222982: Virtus Metabolic Monitor (2023), 0 descendants of its own

## Indications for use
The Q-NRG & Q-NRG+ Portable Metabolic Monitors are indicated for the measurement of Resting Energy Expenditure (REE) for spontaneously breathing and (Q-NRG+ only) ventilated patients, within the following populations: - Spontaneously breathing subjects >15 kg (33 lb) when using a canopy; - Spontaneously breathing subjects age >6 and >10 kg (22 lb) when using a face mask; - Ventilated subjects age >10 and >10 kg (22 lb). The Q-NRG & Q-NRG+ Portable Metabolic Monitors are intended to be used in professional healthcare facilities only (limited to ICUs for ventilated patients).

Source page: https://510kreport.com/device/K190800
Methodology: https://510kreport.com/methodology