# K081037: Watch-Pat 200I (WP200I)

- Pathway: 510(k) (Special)
- Applicant: Itamar Medical
- Decided: Jun 9, 2008 after 59 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: 1 generation back to K042916 (2004). 1 ancestor in all.
25 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042916: Watch Pat 100S, Itamar Medical (2004) Summary page 2.

## Most influential descendants
- K081982: Watch-Pat 200S-2 (WP200S-2) (2008), 24 descendants of its own
- K102567: Watch-Pat 200S-3 (WP200S-3) (2011), 23 descendants of its own
- K133859: Watch-PAT200U (WP200U) (2014), 22 descendants of its own
- K161579: Watch-PAT200U (2017), 20 descendants of its own
- K180775: Watch-PAT300 (2018), 12 descendants of its own

## Indications for use
The WATCH PAT TM 200i ("WP200i") is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200i is a diagnostic aid for the detection of sleep-related breathing disorders and rapid eye movement ("REM") sleep stages. The WP200i generates a peripheral arterial tonometry ("PAT"), respiratory disturbance index ("PRDI'), and PAT REM sleep stage identification ("PREM"). The WP200i's PREM provides supplemental information to its PRDI. The WP200i's PREM is 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. The WP200i is not indicated for children less than 17 years old. The WP200i is contraindicated for patients with latex allergy.

Source page: https://510kreport.com/device/K081037
Methodology: https://510kreport.com/methodology