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WatchPAT400 (WP400)

by Itamar Medical Ltd

510(k) K250460

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250460↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250460 Date5 Sep 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250460 decided 5 Sep 2025 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
MNR
FDA applicant
Itamar Medical , Ltd.
Device class
Class II
Regulation
21 CFR Part 868.2375
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Devices cleared under K250460

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K250460
UDI-DISize and differences
WatchPAT400
ITAMAR MEDICAL LTD
AS2110900 / WatchPAT40007290109223568 —On the market

Similar devices

Other devices filed under FDA product code MNR (Ventilatory Effort Recorder).

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