FDA 510(k) · Itamar
K250460: WatchPAT400 (WP400) (Itamar Medical , Ltd.)
Itamar Medical , Ltd. received FDA 510(k) K250460 for WatchPAT400 (WP400), with a decision date of Sep 5, 2025 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K250460 |
|---|---|
| Pathway | 510(k) |
| Applicant | Itamar Medical , Ltd. |
| Device name | WatchPAT400 (WP400) |
| Product code | MNR: Ventilatory Effort Recorder |
| Regulation (21 CFR) | 868.2375 |
| Device class | Class 2 |
| Date received | Feb 18, 2025 |
| Decision date | Sep 5, 2025 |
| 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 WatchPAT400 (WP400) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The device is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (REM Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP400 generates a peripheral arterial tonometry (“PAT”), Respiratory Disturbance Index ("pRDI"), Apnea-Hypopnea index ("pAHI"), Central Apnea- Hypopnea index ("pAHIc"), sleep staging identification (pSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The device’s pSTAGES and snoring level and body position provide supplemental information to its pRDI/pAHI/pAHIc. The device’s pSTAGES and snoring level and body position are not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted. pAHIc is indicated for use in patients 17 years and older. All other parameters 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.
Later records that cite K250460
- K254042 WatchPAT SW (Itamar, Jul 31, 2026, MNR)
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.