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WatchPAT ONE

by Itamar Medical Ltd

510(k) K183559

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) K183559↗

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 NumberK183559 Date5 Jun 2019ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K183559 decided 5 Jun 2019 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  • Withdrawn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 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.

Devices cleared under K183559

7 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 K183559
UDI-DISize and differences
12 WatchPAT ONE-M Probes
ITAMAR MEDICAL LTD
AC2101360 / 12 WatchPAT ONE-M Probes07290109223025 —On the market
WatchPAT ONE (Canada)
ITAMAR MEDICAL LTD
AC2111801 / WatchPAT ONE (Canada)07290109223254 —On the market
WatchPAT ONE E
ITAMAR MEDICAL LTD
AC2110850 / WatchPAT ONE E07290109222547 —On the market
WatchPAT ONE E (Canada)
ITAMAR MEDICAL LTD
AC2111851 / WatchPAT ONE E (Canada)07290109223230 —On the market
WatchPAT ONE-M
ITAMAR MEDICAL LTD
AC2110860 / WatchPAT ONE-M07290109223032 —On the market
WatchPAT ONE-M (Canada)
ITAMAR MEDICAL LTD
AC2111861 / WatchPAT ONE-M (Canada)07290109223216 —On the market
WatchPATONE
ITAMAR MEDICAL LTD
AC2110800 / WatchPATONE07290109222424 —On the market

Similar devices

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

Other devices from Itamar Medical Ltd

See all devices from Itamar Medical Ltd →