CardioQ-EDM+, CardioQ-EDM
510(k) K172457
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK172457 | Date28 Jun 2018 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
- 510(k) Number
- FDA Product Code
- DPW
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2100
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The CardioQ-EDM+ and CardioQ-EDM are blood flowmeters designed to measure and monitor cardiac output and other haemodynamic parameters in cardiovascular patients. These devices utilise the thermal dilution technique to provide real-time data on blood flow, stroke volume, and cardiac index, supporting clinical assessments in critical care and perioperative settings.
These devices are intended for single-use and are supplied as sterile systems for use in hospital environments. They are classified as Class II medical devices under FDA regulations and comply with the Medical Device Directive (MDD) in the EU. The CardioQ-EDM+ and CardioQ-EDM are non-MRI compatible and require proper storage as per manufacturer instructions to maintain performance. Authorisations include FDA 510(k) clearance (K172457) and MDD compliance (registration number 8020605).
Other devices from Deltex Medical
Questions
AI-generated answers, 18 Sep 2026
Are these devices reusable or designed for single-use in clinical settings?
The CardioQ-EDM+ and CardioQ-EDM are explicitly designed for single-use only. They are supplied as sterile systems, which aligns with hospital infection control protocols and ensures patient safety by preventing cross-contamination between patients.
What types of haemodynamic parameters can these devices measure in real-time, and where are they typically used?
These devices use thermal dilution technology to measure cardiac output, stroke volume, and cardiac index in real-time. They are primarily used in critical care and perioperative settings to support clinical assessments of cardiovascular patients, such as those undergoing surgery or in intensive care.
How should I store these devices to maintain their performance and sterility?
The manufacturer specifies that these devices require proper storage as per their instructions to preserve performance and sterility. Since they are single-use and sterile upon packaging, storage should follow standard medical device protocols—typically in a clean, dry environment away from direct sunlight or extreme temperatures—until immediate clinical use.
Are these devices compatible with MRI machines, and if not, what precautions should be taken?
The CardioQ-EDM+ and CardioQ-EDM are non-MRI compatible. This means they should not be used in or near MRI environments, as exposure to magnetic fields could compromise device function or safety. Clinicians should ensure these devices are removed from patients before MRI procedures and stored away from MRI areas.
What regulatory pathways have these devices undergone, and which agencies have authorized their use?
The devices have received FDA 510(k) clearance (K172457) under the Traditional pathway, classified as Class II devices, and are compliant with the EU Medical Device Directive (MDD) with registration number 8020605. These authorizations confirm their safety and effectiveness for measuring haemodynamic parameters in the specified clinical settings.