# K190282: Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical, Ltd.
- Decided: May 24, 2019 after 102 days
- Product code: DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4220
- Recalls of this device: none
- 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.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060053: Stockert S5 System, Sorin Group Deutschland GmbH (2006) Summary page 5.

## Indications for use
The Quantum Smart Occluder is indicated for use as an accessory with the Quantum Pump Console for up to 6 hours in the extracorporeal circulation of blood for 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/K190282
Methodology: https://510kreport.com/methodology