# K150347: Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+

- Pathway: 510(k) (Traditional)
- Applicant: Deltex Medical Limited
- Decided: Jul 24, 2015 after 163 days
- Product code: DPW (Flowmeter, Blood, Cardiovascular)
- Device class: 2
- Regulation: 21 CFR 870.2100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K851426 (1985). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132139: Deltex Medical Cardioq-Edm+, Deltex Medical Limited (2013) Summary page 5.
- K111542: Deltex Medical Cardioq Edm, Deltex Medical Limited (2011) Summary page 5.

## Indications for use
The Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM cardiac function and fluid status monitoring system is designed to provide clinicians with real-time information about a patient's left ventricular blood flow and key hemodynamic parameters. The Deltex Medical CardioQ-EDM+ / Deltex Medical CardioQ-EDM beat-to-beat data on cardiovascular status can be used by the managing clinician to evaluate and optimize hemodynamic performance in anesthetized, sedated or conscious patients in the operating room, intensive care unit, emergency room or ward.

Source page: https://510kreport.com/device/K150347
Methodology: https://510kreport.com/methodology