# K163657: Quantum Workstation

- Pathway: 510(k) (Special)
- Applicant: Spectrum Medical, Ltd.
- Decided: Jan 18, 2017 after 26 days
- Product code: DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931968 (1993). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071725: M2 Monitor, Spectrum Medical, Ltd. (2007) Summary page 4.

## Most influential descendants
- K181923: Quantum Workstation 12.1 (2018), 1 descendant of its own
- K202557: Quantum Workstation 12 Elite (2020), 0 descendants of its own

## Indications for use
The intended use of the Quantum Workstation is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation is configured to measure and display the following measurements: SaO2 Arterial Saturation (%) SvO2 Venous Saturation (%) Hb Hemoglobin (g/L and gm/dl) Hct Calculated Hematocrit (%) The Workstation provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms. The Workstation's monitoring and alarm functionality does not directly control patient care. The User makes clinical judgments regarding the treatment of the patient as a result of information displayed by the Workstation.

Source page: https://510kreport.com/device/K163657
Methodology: https://510kreport.com/methodology