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WatchPAT ONE

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K183559

by Itamar Medical Ltd

Identifiers

510(k) Number
K183559 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 WatchPAT ONE is a Ventilatory Effort Recorder, designed to monitor and record respiratory effort and apnea events during sleep. It employs peripheral arterial tone (PAT) technology to assess breathing patterns and detect obstructive sleep apnea (OSA) episodes by analyzing changes in blood volume in the finger.

This device is intended for single-use in clinical or home settings, supplied as a non-sterile, non-invasive system. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and EU MDR authorization. The device requires no special storage conditions and is compatible with MRI environments, though specific safety protocols should be followed.

Frequently asked questions

How does the WatchPAT ONE monitor sleep-related breathing issues, and where is it typically used?

The WatchPAT ONE uses peripheral arterial tone (PAT) technology to measure changes in blood volume in the finger, which helps detect respiratory effort and obstructive sleep apnea (OSA) episodes during sleep. It is designed for single-use in both clinical settings, such as hospitals or sleep labs, and home environments for patient monitoring.

Is the WatchPAT ONE reusable, and what are the storage requirements for this device?

The WatchPAT ONE is explicitly intended for single-use only, meaning each unit is meant to be used once and then discarded. Since it is non-sterile and non-invasive, no special storage conditions (like refrigeration or controlled humidity) are required. It can be stored at room temperature until use.

Can the WatchPAT ONE be used in an MRI environment, and are there any specific safety considerations?

Yes, the WatchPAT ONE is compatible with MRI environments, but users should follow standard safety protocols for non-metallic, non-invasive devices in such settings. The device itself does not contain magnetic or conductive materials that could interfere with MRI operations, but facility-specific guidelines should always be consulted.

What regulatory pathways has the WatchPAT ONE followed, and what classification does it hold?

The WatchPAT ONE has received FDA 510(k) clearance under the Traditional pathway, classified as a Class II medical device. It is also authorized under the EU Medical Device Regulation (MDR), confirming its compliance with both U.S. and European regulatory standards for ventilatory effort recording.

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.

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) K183559 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 18, 2026