# WatchPAT ONE

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

- Canonical page: <https://devicerts.com/devices/watchpat-one-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 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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K183559 · decision 2019-06-05 · decision SESE · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K183559 [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: WatchPAT ONE, Itamar Medical Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/watchpat-one-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/watchpat-one-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/watchpat-one-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.