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Physiological Monitor, Models 401, 402 & 403

FDA 510(k)

Class II (US FDA 510(k))

510(k) K862647

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K862647 FDA 510(k)
FDA Product Code
DSK FDA 510(k)
Models / Variants
401 FDA 510(k)
402 FDA 510(k)
403 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1110 FDA 510(k)
Regulation Number
870.1110 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Physiological Monitor designed for continuous, real-time monitoring of vital physiological signals, including blood pressure, ECG, and respiratory parameters. It is classified under the Computer, Blood-Pressure nomenclature and is intended for use in clinical settings to support diagnostic imaging synchronization, particularly in cardiovascular applications.

The monitor is supplied as a reusable medical device and is regulated under 21 CFR 870.1110, with an FDA 510(k) clearance (K862647) granted through the Traditional pathway. Models 401, 402, and 403 are intended for use in hospital, cardiac catheterization, and imaging environments, though no specific MRI safety classification is stated. Storage and handling follow standard sterile or non-sterile medical device protocols as defined by the manufacturer.

Frequently asked questions

What clinical environments is this physiological monitor designed for, and how does that differ between the models 401, 402, and 403?

The Physiological Monitor (Models 401, 402, and 403) is specifically designed for continuous, real-time monitoring of vital signs like blood pressure, ECG, and respiratory parameters. Model 401 is intended for general hospital use, while Models 402 and 403 are tailored for cardiac catheterization labs and imaging environments, respectively. The distinction lies in their specialized applications within these settings, particularly supporting diagnostic imaging synchronization in cardiovascular procedures.

Is this device single-use or reusable, and what are the storage and handling requirements?

This device is classified as a reusable medical device. Storage and handling follow standard protocols for reusable medical devices, as outlined by the manufacturer. Since it is not explicitly labeled as sterile, it should be cleaned, disinfected, and maintained according to Ivy Biomedical Systems’ guidelines to ensure proper functionality and safety for repeated use.

What types of vital signs does this monitor track, and how does it support diagnostic imaging synchronization?

The monitor tracks blood pressure, ECG, and respiratory parameters in real-time. Its design allows for synchronization with diagnostic imaging, particularly in cardiovascular applications, ensuring precise timing and alignment of physiological data with imaging procedures like cardiac catheterization or other diagnostic studies.

What regulatory pathway was used for FDA clearance, and what does that mean for its use in clinical settings?

The Physiological Monitor received FDA clearance through the Traditional 510(k) pathway, specifically under the classification of a Computer, Blood-Pressure device. This means the device was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness. Clinicians can rely on this clearance as evidence of regulatory scrutiny before use in hospital, cardiac catheterization, or imaging environments.

Are there any specific MRI safety considerations mentioned for these models?

The device description does not explicitly state whether any of the models (401, 402, or 403) are MRI-safe or have been tested for use in MRI environments. If MRI compatibility is required, additional verification from the manufacturer would be necessary to ensure safe operation in such settings.

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: PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 - BEUDAMED, PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403 510(k) K862647 - fda.report, K854840 FDA 510(k) - PHYSIOLOGICAL MONITOR, Ivy Operator Manuals - Ivy Biomedical Systems

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ivy Biomedical Systems, Inc.

Sources (1)

  • FDA 510(k) K862647 24 fields · synced Sep 18, 2026