# WatchPAT400 (WP400)

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

- Canonical page: <https://devicerts.com/devices/watchpat400-wp400-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 WatchPAT400 (WP400) is a Ventilatory Effort Recorder, designed to monitor breathing patterns and effort during sleep. It provides continuous, non-invasive assessment of respiratory events, including apneas and hypopneas, by combining oximetry and actigraphy data to evaluate sleep-disordered breathing.

This device is intended for use in clinical and home settings to evaluate ventilatory effort and breathing frequency. Supplied as a reusable medical device, it operates on 1.5V DC and meets IP22 protection standards. Authorized under FDA 510(k) and MDR, the WatchPAT400 (WP400) is classified as a Class II device under regulation 21 CFR 868.2375 and product code MNR. It requires proper calibration and maintenance as specified in manufacturer instructions.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K250460 · decision 2025-09-05 · decision SESE · status: Active
- **EUDAMED** · CE/MDR · European Union · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K250460 [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: WatchPAT400 (WP400), Itamar Medical Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/watchpat400-wp400-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/watchpat400-wp400-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/watchpat400-wp400-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.