IMED-Z Fluid Status Monitor
510(k) K142503
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK142503 | Date5 Jun 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DSB
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2770
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The IMED-Z Fluid Status Monitor is an impedance plethysmograph designed for noninvasive monitoring of fluid status in patients. It measures bioimpedance changes to assess body fluid distribution, aiding in the evaluation of hydration and edema levels. This device supports clinical decision-making for patients with conditions affecting fluid balance, such as heart failure or renal disease.
The device is supplied as a reusable medical instrument paired with single-use, self-adhesive silver/silver chloride electrodes. It operates in clinical settings under physician supervision and requires no specific sterility beyond standard electrode hygiene. The IMED-Z Fluid Status Monitor is classified as a Class II device under FDA regulations and holds a 510(k) clearance (K142503) for cardiovascular applications. Compliance with FDA guidelines ensures its use in monitored environments for accurate fluid status assessment.
Questions
AI-generated answers, 1 Oct 2026
What is the IMED-Z Fluid Status Monitor used for?
The IMED-Z Fluid Status Monitor is designed for noninvasive monitoring of fluid status in patients. It measures bioimpedance changes to assess body fluid distribution, helping clinicians evaluate hydration levels and detect edema. This is particularly useful for patients with conditions like heart failure or renal disease, where fluid balance is critical for treatment decisions.
How is the IMED-Z Fluid Status Monitor supplied, and what does this mean for clinical use?
The device is supplied as a reusable medical instrument paired with single-use, self-adhesive silver/silver chloride electrodes. This setup ensures that the reusable monitor remains sterile and hygienic, while the electrodes—being single-use—eliminate cross-contamination risks between patients. Clinicians only need to maintain standard electrode hygiene, as the device itself does not require additional sterility measures beyond routine cleaning.
Is the IMED-Z Fluid Status Monitor approved for specific medical conditions?
The device holds FDA 510(k) clearance (K142503) for cardiovascular applications, specifically for use in monitoring fluid status. While it is designed to aid in the evaluation of hydration and edema—common concerns in patients with heart failure or renal disease—its approval is based on its intended use as an impedance plethysmograph, not as a standalone diagnostic tool for any specific condition. Always follow physician supervision and clinical guidelines for patient-specific applications.
What are the key specifications or models associated with the IMED-Z Fluid Status Monitor?
The IMED-Z Fluid Status Monitor is classified under the FDA’s product code DSB and falls under the regulation number 870.2770. It is registered with multiple FEI numbers, including 3018940143, 3003971136, and others, indicating its compliance with regulatory requirements. These identifiers are used for tracking and submission purposes but do not imply variations in the device’s core functionality. The device is standardized for clinical use in cardiovascular monitoring.
How should the IMED-Z Fluid Status Monitor be stored, and what considerations should clinicians keep in mind?
While the device data does not specify storage conditions, reusable medical devices like the IMED-Z Fluid Status Monitor should generally be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The single-use electrodes should be stored according to their packaging instructions, typically in a sealed pouch until use. Clinicians should also ensure the device is properly cleaned and maintained between uses to preserve its accuracy and longevity, adhering to manufacturer guidelines for optimal performance.