# K080427: Watch-Pat Model 100S-2

- Pathway: 510(k) (Traditional)
- Applicant: Itamar Medical
- Decided: May 23, 2008 after 98 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: 3 generations back to K910870 (1991). 14 ancestors in all.
25 later devices descend from it; 1 cites it directly.
0 of 40 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.
- K002622: Biosleep, Oxford Biosignals Limited (2000) Summary page 2.
- K981034: Silent Night II, Sleep Solutions, Inc. (1998) Summary page 2.
- K971813: EMBLA, Ferguson Medical (1998) 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-PATlOOS-2 (WP100S-2) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S-2 is a diagnostic aid for the detection of sleep related breathing disorders and sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake). The WP100S-2 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI") and PAT sleep staging identification (PSTAGES). The WP100S-2's PSTAGES provides supplemental information to its PRDI/PAHI. The WP100S-2's PSTAGES 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-2 is not indicated for children less than 17 years old.

Source page: https://510kreport.com/device/K080427
Methodology: https://510kreport.com/methodology