510(k) · Cleared
ClearedQuark Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cosmed Srl · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 11, 2012 after a 328-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Dec 11, 2012
- Review
- 328 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120146 | Quark Series | Cosmed Srl | 2012 | — |
| +1 | K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors | Cosmed Srl | 2020 | — |
| +2 | K222982 | Virtus Metabolic Monitor | Virtus Technology Aps | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
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 CBK? 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190800 | Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors | 2020 | 1 |
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?
- Of its descendants, K190800 (Cosmed Srl, 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
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…
Read the full statement (193 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120146 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120146: Quark Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120146
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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