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LIDCOplus Hemodynamic Monitor System, Model HM 70

FDA 510(k)

Class II (US FDA 510(k))

510(k) K023960

by LiDCO Ltd

Identifiers

510(k) Number
K023960 FDA 510(k)
FDA Product Code
DXG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1435 FDA 510(k)
Regulation Number
870.1435 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The LIDCOplus Hemodynamic Monitor System is a diagnostic device for measuring blood pressure, cardiac output, and associated hemodynamic parameters. It utilizes two technologies: continuous arterial waveform analysis (PulseCO™) and a single point lithium indicator dilution calibration system to provide continuous assessment of hemodynamic status.

The system is intended for use in critical care and surgery settings. It is supplied as a reusable device and has received FDA 510(k) clearance with the product code DXG. The device is manufactured by LiDCO Ltd and is designed for efficient setup and simple operation with an intuitive display for effective hemodynamic management.

Frequently asked questions

What is the LIDCOplus Hemodynamic Monitor System Model HM 70 used for?

The LIDCOplus Hemodynamic Monitor System Model HM 70 is a diagnostic device used to measure blood pressure, cardiac output, and associated hemodynamic parameters. It combines continuous arterial waveform analysis (PulseCO™) with a single-point lithium indicator dilution calibration system to provide continuous assessment of hemodynamic status, supporting clinical decision-making in critical care and surgery settings.

Is the LIDCOplus Hemodynamic Monitor System Model HM 70 reusable or single-use?

The LIDCOplus Hemodynamic Monitor System Model HM 70 is supplied as a reusable device. This means the main monitor unit is designed for repeated use after appropriate cleaning and maintenance, consistent with its intended use in critical care and surgical environments where ongoing hemodynamic monitoring is required.

What regulatory pathway was used for the LIDCOplus Hemodynamic Monitor System Model HM 70?

The LIDCOplus Hemodynamic Monitor System Model HM 70 received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device. The clearance was granted under product code DXG, with the decision date of January 9, 2003, and K-number K023960, confirming its regulatory pathway as a 510(k) submission.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Lidcoplus Hemodynamic Monitor System, Model Hm 70 (K023960) — Fda 510 ..., LiDCOplus | LiDCO - Hemodynamic Monitoring for the entire patient pathway, Masimo - Masimo LiDCO™ Hemodynamic Monitoring System, Lidcoplus Hemodynamic Monitor System, Model Hm 70

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
LiDCO Ltd
FDA Applicant
Lidco, Ltd.

Sources (1)

  • FDA 510(k) K023960 24 fields · synced Sep 24, 2026