FDA 510(k) · Itamar
K254042: WatchPAT SW (Itamar Medical , Ltd.)
Itamar Medical , Ltd. received FDA 510(k) K254042 for WatchPAT SW, with a decision date of Jul 31, 2026 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K254042 |
|---|---|
| Pathway | 510(k) |
| Applicant | Itamar Medical , Ltd. |
| Device name | WatchPAT SW |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Dec 16, 2025 |
| Decision date | Jul 31, 2026 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The WatchPAT SW analyzes data recorded by WatchPAT devices (WP300, WP1, WP400) and automatically generates respiratory indices, sleep stages, snoring level, and body position. WatchPAT SW is intended for use under the direction of a healthcare professional to aid in the diagnosis of obstructive and central sleep related breathing disorders. Central indices are indicated for use in patients 17 years and older. All other outputs are indicated for 12 years and older.
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code MNR is "Ventilatory Effort Recorder", class 2, 21 CFR 868.2375.
Our labels for filtering: claim Sleep apnea, sensor Wrist PPG. These are heuristics, not FDA fields.