Impedimed Extracellular Fluid Analysis, Model L-Dex U400

No FDA recalls found in the data synced 5 Oct 2026.

Full name

Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400

510(k) Number

K080825 ↗

FDA Product Code

OBH

FDA applicant

Impedimed Pty , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.2770

Advisory Committee

Cardiovascular

FDA Decision

SESK Substantially Equivalent — Kit

• Impedimed-Extracellular Fluid Analysis

  Class II

  FDA 510(k) K050415 Active Cleared 30 Mar 2007

• Impedimed - Body Composition Analyzer, Model Imp SFB7

  Class II

  FDA 510(k) K052319 Active Cleared 4 Apr 2006

• Impedimed - Body Composition Analysis

  Class II

  FDA 510(k) K050395 Active Cleared 13 Jul 2005

• What is the L-Dex U400 used for?

  The L-Dex U400 is a bioelectrical impedance analyzer designed to measure differences in extracellular fluid volume in extremities. By using impedance ratios, it quantifies fluid accumulation, helping clinicians diagnose and monitor conditions like lymphedema and assess lymphatic or cardiovascular health. Its non-invasive, multi-frequency technology provides objective measurements to support clinical decision-making.

• How is the L-Dex U400 supplied, and is it single-use or reusable?

  The L-Dex U400 is a portable, battery-powered device intended for clinical use, including hospitals, outpatient clinics, and research settings. Its usability depends on associated consumables—it can function as either a single-use or reusable system, though sterility requirements are not explicitly detailed in the specifications. The core hardware itself is reusable, while consumables (e.g., electrodes or sensors) may dictate usage per protocol.

• Does the L-Dex U400 require any additional software for operation?

  The L-Dex U400 operates independently as a standalone bioimpedance monitor, with no mandatory software for basic functionality. However, optional PC software—such as *Lymphedema Analysis*—can be paired with the device to process and analyze data further. This software is not a core component but enhances workflows for clinicians managing fluid-related conditions.

• What regulatory clearance does the L-Dex U400 hold?

  The L-Dex U400 holds FDA 510(k) clearance under the classification *Monitor, Extracellular Fluid, Lymphedema, Extremity*, with the clearance number K080825. It is categorized as a Class II device, adhering to U.S. regulatory standards for bioelectrical impedance analyzers. The device’s approval reflects its compliance with safety and performance requirements for diagnostic monitoring.

• Can the L-Dex U400 measure fluid changes in any limb, or are there size limitations?

  The L-Dex U400 is designed to assess fluid accumulation in extremities (arms or legs) using multi-frequency bioimpedance technology. While the device itself is not limited to specific limb sizes, accurate measurements depend on proper electrode placement and adherence to manufacturer guidelines for consumables. Clinicians should follow the provided instructions to ensure reliable results across different patient anatomies.