# K120146: Quark Series

- Pathway: 510(k) (Traditional)
- Applicant: Cosmed Srl
- Decided: Dec 11, 2012 after 328 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K190800: Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors (2020), 1 descendant of its own
- K222982: Virtus Metabolic Monitor (2023), 0 descendants of its own

## Indications for use
The COSMED Quark Series system Is a modular system with multiple configurations, allowing the following measurements: Spirometry. Lung Function Testing, Cardiopulmonary Exercise Testing, Resting Metabolism. The system and Its accessories ame indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It is Intended to assist a clinician in the diagnosis of cardlo-pulmonary disease conditions. Quark SPIRO: Pulmonary Function testing adults. Spontaneously breathing patients, healthy or affected by respiratory diseases such as asthma or COPD. Quark PFT: Pulmonary Function testing adults. Spontaneously breathing patients, healthy or affected by respiratory diseases such as asthma or COPD. Quark CPET: Pulmonary Function testing - Age 6 to adults. Spontaneously breathing patients, healthy or affected by diseases limiting exercise tolerance. Quark RMR: Measurement of Resting Metabolism (face mask) - age 6 to adults; Measurement of Resting Metabolism (canopy dilution) - 15Kg/30Lb to adults; Measurement of Resting Metabolism (Ventilated patients) - age 10 to adults. Spontaneously breathing patients; Ventilated patients with some limitations as in accordance with labeling. Quark SPIRO and Quark PFT also allows the Airways Resistance Test with the occlusion technique (Rocc test) for young patients from 3 to 6 years old.

Source page: https://510kreport.com/device/K120146
Methodology: https://510kreport.com/methodology