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Model 509M Pulse Oximeter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032755

by Respironics Novametrix, LLC

Identifiers

510(k) Number
K032755 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 509M Pulse Oximeter is a non-invasive monitoring device classified as a pulse oximeter. It measures functional arterial oxygen saturation (SpO₂) and pulse rate continuously using a ratiometric technique that analyzes red and infrared light absorbance through arterial hemoglobin. This device is designed to provide real-time, non-invasive assessment of oxygenation and heart rate, critical for patient monitoring in clinical settings.

The Model 509M is intended for use in neonatal and pediatric environments, where continuous monitoring is essential. Supplied as a reusable device, it requires proper calibration and maintenance per manufacturer guidelines. The device holds an FDA 510(k) clearance under the traditional review pathway, with a classification under product code DQA. Storage and handling must adhere to regulatory and clinical best practices to ensure accuracy and reliability.

Frequently asked questions

What is the Model 509M Pulse Oximeter used for?

The Model 509M Pulse Oximeter is designed for continuous, non-invasive monitoring of functional arterial oxygen saturation (SpO₂) and pulse rate in neonatal and pediatric patients. It uses ratiometric light absorbance through arterial hemoglobin to provide real-time data, which is critical for assessing oxygenation and heart rate in clinical settings where continuous monitoring is essential.

Is the Model 509M Pulse Oximeter reusable or single-use?

The Model 509M Pulse Oximeter is a reusable device. It requires proper calibration and maintenance as outlined in the manufacturer’s guidelines to ensure accuracy and reliability over repeated use. Regular upkeep is necessary to maintain performance standards.

How is the Model 509M Pulse Oximeter supplied and stored?

The device is supplied as a reusable unit and must be stored and handled according to regulatory and clinical best practices. Proper storage conditions help preserve its functionality and accuracy. The manufacturer provides specific guidelines for calibration, maintenance, and storage to ensure optimal performance.

What regulatory pathway does the Model 509M Pulse Oximeter follow?

The Model 509M Pulse Oximeter holds an FDA 510(k) clearance under the traditional review pathway. This clearance was granted following a determination of substantial equivalence to a predicate device, ensuring it meets regulatory standards for safety and effectiveness in its intended use.

Can the Model 509M Pulse Oximeter be used in adult patients?

The Model 509M Pulse Oximeter is specifically designed for neonatal and pediatric environments. While its technology may function in other settings, its intended use and regulatory clearance are focused on monitoring oxygenation and heart rate in infants and children. Always refer to the manufacturer’s instructions for proper usage.

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: fda.innolitics.com, FDA Browser - Cleared 510 (K) - MODEL 509M PULSE OXIMETER, MODEL 509M ..., PDF MAY 2 1 2004. - accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Respironics Novametrix, LLC
FDA Applicant
Respironics Novametrix, Inc.

Sources (1)

  • FDA 510(k) K032755 24 fields · synced Oct 1, 2026