# K210669: Quantum Mini Ventilation Module

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical, Ltd.
- Decided: May 4, 2021 after 60 days
- Product code: DTX (Gas Control Unit, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931968 (1993). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202733: Quantum Ventilation Module, Spectrum Medical, Ltd. (2020) Summary page 4.

## Indications for use
The Quantum Mini Ventilation Module is intended to provide independently regulated 02 outputs for a controlled flow of 02 into the ECC circuit. The Quantum Mini Ventilation Module is an accessory that works with the Quantum workstation. The following parameters are provided by the Quantum Mini Ventilation Module: * Control of gas flow (02) * Extracorporeal gas flow measurements for 02 The Quantum Mini Ventilation Module is only to be used by an experienced and trained clinician. It is not intended to be used by a patient or other untrained personnel.

Source page: https://510kreport.com/device/K210669
Methodology: https://510kreport.com/methodology