# K223675: WatchPAT ONE (WP1)

- Pathway: 510(k) (Special)
- Applicant: Itamar Medical, Ltd.
- Decided: Jan 6, 2023 after 30 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: 10 generations back to K913396 (1992). 51 ancestors in all.
2 later devices descend 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)
- K222331: WatchPAT300 (WP300), Itamar Medical, Ltd. (2022) Summary page 4.

## Most influential descendants
- K250460: WatchPAT400 (WP400) (2025), 1 descendant of its own
- K254042: WatchPAT SW (2026), 0 descendants of its own

## Indications for use
The WatchPAT ONE (WP1) device is a noninvasive home care device for use with patients suspected to have sleep related breathing disorders. The WP1 is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP1 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP1's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHI/PAHIc. The WP1'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/K223675
Methodology: https://510kreport.com/methodology