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Model 303D and 403D Adult Heart Rate & Respirator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K880066

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K880066 FDA 510(k)
FDA Product Code
DRT FDA 510(k)
Models / Variants
303d FDA 510(k)
403d Adult Heart Rate FDA 510(k)
Respirator FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2300 FDA 510(k)
Regulation Number
870.2300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Cardiac Monitor (including cardiotachometer and rate alarm) designed to measure and display adult heart rate and respiration. It provides real-time monitoring of cardiac and respiratory parameters, supporting clinical assessment and patient safety during diagnostic or therapeutic procedures.

The Model 303D and 403D are intended for use in clinical settings, such as radiology, nuclear medicine, or cardiac care, where precise timing and synchronization are required. Supplied as a reusable device, it requires proper cleaning and maintenance per manufacturer guidelines. Authorized under FDA 510(k) clearance (K880066) as a Class II device under product code DRT, it adheres to regulatory standards for cardiac monitoring equipment.

Frequently asked questions

What clinical settings is this device designed for and why is precise timing important in those environments?

The Model 303D and 403D are specifically designed for clinical settings like radiology, nuclear medicine, and cardiac care, where accurate monitoring of heart rate and respiration is critical. Precise timing and synchronization are essential in these environments to ensure patient safety during procedures that may involve contrast agents, radiation exposure, or invasive interventions. Real-time monitoring helps clinicians assess patient stability and respond promptly to any changes in cardiac or respiratory parameters.

Is this device single-use or reusable, and what maintenance is required if it is reusable?

The Model 303D and 403D are reusable devices. Since they are intended for repeated use, proper cleaning and maintenance per the manufacturer’s guidelines are required to ensure accuracy, reliability, and infection control. Regular upkeep is necessary to maintain performance standards for continuous patient monitoring.

How is the regulatory status of this device determined, and what does the FDA 510(k) clearance indicate?

The device was cleared through the FDA’s 510(k) process, which evaluates whether it is *substantially equivalent* to a legally marketed predicate device. The clearance (K880066) under product code DRT confirms it meets regulatory standards for cardiac monitoring equipment as a Class II device, ensuring it complies with safety and performance requirements for clinical use.

Are there different models available, and if so, how do they differ in terms of functionality or intended use?

The Model 303D and Model 403D are both designed for adult heart rate and respiration monitoring, but their specific configurations (e.g., display features, connectivity options, or additional alarms) may vary. While the data does not detail exact functional differences, both are intended for the same core purpose—real-time cardiac and respiratory assessment in clinical settings requiring precise timing.

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: Model 303d and 403d Adult Heart Rate & Respirator, Model 303d and 403d Adult Heart Rate & Respirator, K880066 FDA 510 (k) - MODEL 303D AND 403D ADULT HEART RATE & ..., Model 303d And 403d Adult Heart Rate & Respirator 510 (k) FDA Premarket ...

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) K880066 24 fields · synced Oct 6, 2026