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WatchPAT300 (WP300)

by Itamar Medical Ltd

510(k) K222331

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) K222331↗

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 · Special NumberK222331 Date14 Sep 2022ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K222331 decided 14 Sep 2022 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  • Withdrawn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 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.

Devices cleared under K222331

5 devices · 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 K222331
UDI-DISize and differences
12 uPAT Probes
ITAMAR MEDICAL LTD
AC2101300 / 12 uPAT Probes07290109222103
Single use: yes
On the market
Central Plus Sensor
ITAMAR MEDICAL LTD
AC3000115 / Central Plus Sensor07290109223193
Single use: no
On the market
Central Plus Sensor for Watch-PAT200U
ITAMAR MEDICAL LTD
AC3000100 / Central Plus Sensor for Watch-PAT200U07290109222035
Single use: no
No longer on the market
Watch-PAT300
ITAMAR MEDICAL LTD
AS2110701 / Watch-PAT30007290109222455
Single use: no
On the market
Watch-PAT300
ITAMAR MEDICAL LTD
US2110701 / Watch-PAT30007290109222479
Single use: no
On the market

Similar devices

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

Other devices from Itamar Medical Ltd

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