# K042916: Watch Pat 100S

- Pathway: 510(k) (Traditional)
- Applicant: Itamar Medical
- Decided: Dec 29, 2004 after 69 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
No predicates in its family tree.
71 later devices descend from it; 3 cite it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Itamar's Watch PAT 100 (WP100): named in the summary without a submission number
- (no number) Oxford BioSignal's BioSleep (BioSleep): named in the summary without a submission number

## Most influential descendants
- K071230: Apnea Risk Evaluation System (Ares), Model 600 (2007), 43 descendants of its own
- K110705: Apnea Risk Evaluation System (Ares) (2011), 41 descendants of its own
- K111194: Apnea Risk Evaluation System (Ares) (2011), 40 descendants of its own
- K112514: Apnea Risk Evaluation System (Ares) (2012), 38 descendants of its own
- K081037: Watch-Pat 200I (WP200I) (2008), 25 descendants of its own

## Indications for use
The Watch-PAT 100S ("WP100S") device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S is a diagnostic aid for the detection of sleep related breathing disorders and rapid eye movement ("REM") sleep stages. The WP100S generates a peripheral arterial tonometry ("PAT") respiratory disturbance index ("PRDI") and PAT REM sleep stage identification ("PREM"). The WP100S's PREM provides supplemental information to its PRDI. The WP100S'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 WP100S is not indicated for children less than 17 years old. The WP100S is contraindicated for patients with latex allergy.

Source page: https://510kreport.com/device/K042916
Methodology: https://510kreport.com/methodology