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Model 2000 Pulse Oximeter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K982255

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K982255 FDA 510(k)
FDA Product Code
DQA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2700 FDA 510(k)
Regulation Number
870.2700 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Model 2000 Pulse Oximeter is a non-invasive device used to measure and display oxygen saturation levels (SpO₂) and pulse rate in patients. It operates by emitting light through a patient’s finger, earlobe, or other perfused tissue and analyzing the absorption differences to estimate hemoglobin oxygenation and heart rate, providing real-time physiological monitoring.

This device is supplied as a reusable medical instrument and is intended for use in clinical settings such as hospitals, operating rooms, or intensive care units. It requires no sterilization between uses but must be cleaned and maintained according to manufacturer guidelines. The Model 2000 Pulse Oximeter holds FDA 510(k) clearance under the traditional review pathway, classified under product code DQA, and is intended for general pulse oximetry applications as defined by regulatory submissions.

Frequently asked questions

Is the Model 2000 Pulse Oximeter designed for single-use or can it be reused in a clinical setting?

The Model 2000 Pulse Oximeter is classified as a reusable medical instrument. It is intended for repeated use in clinical environments like hospitals, operating rooms, or intensive care units. However, it must be cleaned and maintained according to the manufacturer’s guidelines between uses, as no sterilization is required.

What types of body parts can the Model 2000 Pulse Oximeter measure oxygen saturation and pulse rate on?

The device is designed to measure oxygen saturation (SpO₂) and pulse rate by emitting light through a patient’s finger, earlobe, or any other perfused tissue. This allows for flexible placement depending on the patient’s condition and accessibility.

How is the Model 2000 Pulse Oximeter regulated by the FDA, and what does that mean for its use?

The Model 2000 Pulse Oximeter holds FDA 510(k) clearance under the traditional review pathway, classified under product code DQA (Diagnostic, General and Specialty). This means it has been determined to be substantially equivalent to a legally marketed device already on the market, ensuring it meets regulatory standards for safety and effectiveness in general pulse oximetry applications.

What kind of clinical environments is the Model 2000 Pulse Oximeter intended for?

The device is explicitly intended for use in clinical settings such as hospitals, operating rooms, and intensive care units. Its design supports continuous, real-time monitoring of oxygen saturation and pulse rate, making it suitable for high-acuity patient care environments.

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: IVY BIOMEDICAL SYSTEMS 2000 OPERATOR'S AND SERVICE MANUAL Pdf Download, Ivy Biomedical Systems 2000 Operator's And Service Manual, Ivy biomedical systems 2000 Manuals | ManualsLib, Model 2000 Pulse Oximeter Operators and Service Manual Rev 05, MODEL 2000 PULSE OXIMETER by IVY BIOMEDICAL SYSTEMS, INC. | FDA 510 (k ...

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) K982255 24 fields · synced Sep 18, 2026