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WatchPAT300 (WP300)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K222331

by Itamar Medical Ltd

Identifiers

510(k) Number
K222331 FDA 510(k)
FDA Product Code
MNR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.2375 FDA 510(k)
Regulation Number
868.2375 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The WatchPAT300 (WP300) is a Ventilatory Effort Recorder, designed to monitor respiratory effort and peripheral arterial tonometry signals for sleep-related breathing disorders. It provides non-invasive assessment of sleep apnea by detecting changes in blood flow and respiratory patterns without requiring traditional airflow-based measurements.

This device is intended for use in clinical and home settings to aid in diagnosing sleep apnea. Supplied as a reusable medical instrument, it does not require sterilisation and is classified as a Class II device under FDA regulations. The WatchPAT300 operates in accordance with FDA 510(k) clearance and EU MDR compliance, with no specific MRI safety restrictions stated. It is authorised for use in anaesthesiology and requires proper storage as per manufacturer guidelines.

Frequently asked questions

What clinical settings is the WatchPAT300 primarily designed for, and how does it differ from traditional sleep apnea diagnostic tools?

The WatchPAT300 is designed for use in both clinical and home settings to aid in diagnosing sleep-related breathing disorders, specifically sleep apnea. Unlike traditional tools that rely on airflow-based measurements (e.g., polysomnography), it uses non-invasive monitoring of respiratory effort and peripheral arterial tonometry signals. This approach avoids the need for nasal cannulas or other airflow sensors, making it more comfortable for patients and suitable for home use.

Is the WatchPAT300 reusable, and if so, what are the maintenance requirements?

Yes, the WatchPAT300 is supplied as a reusable medical instrument. It does not require sterilization, but proper storage and handling as per the manufacturer’s guidelines are essential to maintain its functionality and ensure accurate diagnostic results. Regular cleaning and calibration may be necessary to sustain performance over time.

What regulatory pathways has the WatchPAT300 followed, and how does this affect its use in different regions?

The WatchPAT300 has obtained FDA 510(k) clearance and EU MDR compliance, confirming its regulatory authorization in the United States and European Union. These pathways ensure it meets stringent safety and performance standards for use in clinical and home settings. The device’s classification as Class II under FDA regulations further supports its intended use in diagnosing sleep apnea without requiring invasive procedures.

Are there any specific storage instructions for the WatchPAT300, and how should it be handled to ensure optimal performance?

While the device data does not specify exact storage conditions, the manufacturer recommends adhering to their guidelines to preserve functionality. Since it is reusable and not sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper handling, including avoiding physical damage, is critical to maintaining accuracy in detecting respiratory effort and peripheral arterial tonometry signals.

Does the WatchPAT300 have any restrictions on use in environments like MRI facilities?

The device data does not mention any specific MRI safety restrictions for the WatchPAT300. However, since it is a reusable medical instrument used for diagnostic purposes, it should not be exposed to MRI environments unless explicitly tested and approved for such use. Clinicians should verify compatibility with their facility’s MRI protocols before use in those 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: watchpat-300 - ZOLL Itamar - Itamar Medical, PDF Watch _PAT - itamar-medical.com, ITAMAR MEDICAL WATCHPAT 300 OPERATION MANUAL Pdf Download

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Itamar Medical Ltd
FDA Applicant
Itamar Medical , Ltd.

Sources (2)

  • FDA 510(k) K222331 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026