# K250460: WatchPAT400 (WP400)

- Pathway: 510(k) (Traditional)
- Applicant: Itamar Medical, Ltd.
- Decided: Sep 5, 2025 after 199 days
- Product code: MNR (Ventilatory Effort Recorder)
- Device class: 2
- Regulation: 21 CFR 868.2375
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913396 (1992). 52 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223675: WatchPAT ONE (WP1), Itamar Medical, Ltd. (2023) Summary page 5.

## Most influential descendants
- K254042: WatchPAT SW (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K250460
Methodology: https://510kreport.com/methodology