# K111542: Deltex Medical Cardioq Edm

- Pathway: 510(k) (Traditional)
- Applicant: Deltex Medical Limited
- Decided: Oct 20, 2011 after 140 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: 3 generations back to K851426 (1985). 5 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031706: Cardioq, Model 9051-7005, Deltex Medical (2003) Summary page 2.

## Most influential descendants
- K132139: Deltex Medical Cardioq-Edm+ (2013), 2 descendants of its own
- K172457: Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM (2018), 0 descendants of its own
- K150347: Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+ (2015), 0 descendants of its own

## Indications for use
The 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 CardioQ-EDM's 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 sedated patients in the operating room, intensive care unit, emergency room or ward.

Source page: https://510kreport.com/device/K111542
Methodology: https://510kreport.com/methodology