# K173591: Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical, Ltd.
- Decided: Mar 28, 2018 after 127 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: 6 generations back to K931968 (1993). 12 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110957: M4 Monitor, Spectrum Medical, Llp (2011) Summary page 4.

## Most influential descendants
- K181942: Quantum Ventilation Module (2018), 2 descendants of its own
- K202733: Quantum Ventilation Module (2020), 1 descendant of its own
- K210669: Quantum Mini Ventilation Module (2021), 0 descendants of its own

## Indications for use
The Quantum Diagnostic Module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. The Quantum Diagnostic Module is an accessory that only works with the Quantum Workstation. Parameters provided by the Quantum Diagnostic Module include: • Measurement of up to three blood flow channels and arterial and venous flow differential • Indication of gas bubbles • Extracorporeal gas flow measurements (O2, CO2, gas flow, and CO2 removal) • Predicted PO2 and PCO2 • Temperature • Up to three circuit pressure channels • Reservoir level indication The Quantum Diagnostic Module is to only be used by an experienced and trained clinician. The device is not intended to be used by the patient or other untrained personnel.

Source page: https://510kreport.com/device/K173591
Methodology: https://510kreport.com/methodology