# WatchPAT300 (WP300)

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/watchpat300-wp300-mnr>
- Manufacturer: [Itamar Medical Ltd](https://devicerts.com/manufacturers/itamar-medical-ltd) (Israel)
- Device class: Class II (US FDA)
- FDA product code: MNR

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K222331 · decision 2022-09-14 · decision SESE · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K222331 [FDA 510(k)]
- FDA product code: MNR [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 868.2375 [FDA 510(k)]
- Advisory committee: Anesthesiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: WatchPAT300 (WP300), Itamar Medical Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/watchpat300-wp300-mnr (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/watchpat300-wp300-mnr.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/watchpat300-wp300-mnr
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.