WatchPAT ONE (WP1)
510(k) K223675
WatchPAT ONE (WP1) is a medical device (FDA Class II; FDA product code MNR, Ventilatory Effort Recorder) made by Itamar Medical Ltd, cleared under FDA 510(k) K223675 on 6 Jan 2023, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223675 | Date6 Jan 2023 | StatusActive |
Official records
- FDA 510(k) database K223675
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
Devices cleared under K223675
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.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 12 WatchPAT ONE-M Probes | AC2101360 / 12 WatchPAT ONE-M Probes | 07290109223025 | — | On the market |
| WatchPAT ONE (Canada) | AC2111801 / WatchPAT ONE (Canada) | 07290109223254 | — | On the market |
| WatchPAT ONE E | AC2110850 / WatchPAT ONE E | 07290109222547 | — | On the market |
| WatchPAT ONE E (Canada) | AC2111851 / WatchPAT ONE E (Canada) | 07290109223230 | — | On the market |
| WatchPAT ONE-M | AC2110860 / WatchPAT ONE-M | 07290109223032 | — | On the market |
| WatchPAT ONE-M (Canada) | AC2111861 / WatchPAT ONE-M (Canada) | 07290109223216 | — | On the market |
| WatchPATONE | AC2110800 / WatchPATONE | 07290109222424 | — | On the market |
Similar devices
Other devices filed under FDA product code MNR (Ventilatory Effort Recorder).
- SleepImage System by Mycardio, LLC Dba Sleepimage.
- NOX T3 Noxturnal (PC Application) by Nox Medical
- OXI-SNAP by Snap Laboratories, LLC
- BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal by SALTER LABS
- SLEEP PAT 200 DEVICE by Itamar Medical (C.M.) 1997, Ltd.
- MATRx plus by Zephyr Sleep Technologies, Inc.
- BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER by SALTER LABS
- SOMNOLYZER 24X7 by Respironics, Inc.
- Withings Sleep Rx by Withings
- Positional Sleep Assessment System (PoSAS) software by Advanced Brain Monitoring, Inc.