# K172457: Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM

- Pathway: 510(k) (Traditional)
- Applicant: Deltex Medical Limited
- Decided: Jun 28, 2018 after 318 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: 6 generations back to K972320 (1997). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 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 4.
- K140102: Physioflow Q-Link, Vasocom, Inc. (2014) Summary page 4.
- K111542: Deltex Medical Cardioq Edm, Deltex Medical Limited (2011) Summary page 4.

## Indications for use
The CardioQ-EDM series fluid management and cardiac output monitoring systems are designed to provide clinicians with real-time information about patients left ventricular blood flow and key hemodynamic parameters. The CardioQ-EDM series 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. The CardioQ-EDM series monitors when used in Flow Monitoring Mode (esophageal Doppler) or Pressure Monitoring Mode (EDM+ only) are intended for use with adult and pediatric patients. When the CardioQ-EDM series monitors are used for High-Definition Impedance CardioGraphy with a PhysioFlow Q-Link module the intended use is for adult patients only.

Source page: https://510kreport.com/device/K172457
Methodology: https://510kreport.com/methodology