# K240908: Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical, Ltd.
- Decided: Jul 8, 2025 after 462 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K802147 (1980). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201984: MPS 3 ND Myocardial Protection System, Quest Medical, Inc. (2020) Summary page 5.

## Cited in the summary but kept off the family tree
- K001231: The Kalix Implant, New Deal, S.A. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Quantum Micro-Cardioplegia Delivery System is intended for delivery of micro-cardioplegia to the heart during open heart surgery lasting up to six hours in duration. It is intended 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/K240908
Methodology: https://510kreport.com/methodology