# K254042: WatchPAT SW

- Pathway: 510(k) (Traditional)
- Applicant: Itamar Medical, Ltd.
- Decided: Jul 31, 2026 after 227 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: 12 generations back to K913396 (1992). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250460: WatchPAT400 (WP400), Itamar Medical, Ltd. (2025) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K254042
Methodology: https://510kreport.com/methodology