# K173834: Quantum Pump Console

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical, Ltd.
- Decided: May 25, 2018 after 158 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K060053 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
1 of 2 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060053: Stockert S5 System, Sorin Group Deutschland GmbH (2006) Summary page 4.

## Recalls of this device
- Mar 13, 2023 · Class II · Z-0224-2025: The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
- May 29, 2019 · Class I · Z-2238-2019: Potential for Quantum Pump Console, part of the Quantum Perfusion Systems, to unexpectedly shut down while in use.

## Indications for use
The Quantum Pump Console is indicated for use for up to 6 hours in cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

Source page: https://510kreport.com/device/K173834
Methodology: https://510kreport.com/methodology