# K181923: Quantum Workstation 12.1

- Pathway: 510(k) (Special)
- Applicant: Spectrum Medical, Ltd.
- Decided: Aug 17, 2018 after 30 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: 4 generations back to K931968 (1993). 4 ancestors in all.
1 later device descends 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)
- K163657: Quantum Workstation, Spectrum Medical, Ltd. (2017) Summary page 4.

## Most influential descendants
- K202557: Quantum Workstation 12 Elite (2020), 0 descendants of its own

## Indications for use
The intended use of the Quantum Workstation 12.1" is for the non-invasive continuous monitoring of oxygen saturation and haemotocrit / haemoglobin concentration of the blood in an extracorporeal circuit. When using its range of accessories, the Quantum Workstation 12.1" is configured to measure and display the following measurements: Sa02 Arterial Saturation (%) SvO2 Venous Saturation (%) Hb Haemogloblin (g/L and gm/dl and mmol/l) Hct Calculated Haematocrit (%) The Workstation 12.1" provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms. The Workstation 12.1"'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 12.1".

Source page: https://510kreport.com/device/K181923
Methodology: https://510kreport.com/methodology