# K202557: Quantum Workstation 12 Elite

- Pathway: 510(k) (Special)
- Applicant: Spectrum Medical, Ltd.
- Decided: Oct 2, 2020 after 29 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: 5 generations back to K931968 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181923: Quantum Workstation 12.1, Spectrum Medical, Ltd. (2018) Summary page 4.

## Indications for use
The intended use of the Quantum Workstation 12" Elite is for the non-invasive continuous monitoring of oxygen saturation and hematocrit / hemoglobin concentration of the blood and in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12" Elite is configured to measure and display the following measurements: * Sa02 Arterial Saturation (%) * SvO2 Venous Saturation (%) * Hb Hemoglobin (g/L and gm/dl) » Het Calculated Hematocrit (%) * Blood Flow - 2 channels with arterial and venous flow differentials * Pressure & Temperature - 4 channels The Quantum Workstation 12” Elite 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/K202557
Methodology: https://510kreport.com/methodology