510(k) Report

Devices descending from K081037

25 later devices reach Watch-Pat 200I (WP200I) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical200824—
+2K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd.201123—
+3K133859Watch-PAT200U (WP200U)Itamar Medical, Ltd.201422—
+4K161579Watch-PAT200UItamar Medical, Ltd.201720—
+4K153070Watch-PAT200UItamar Medical, Ltd.20160—
+5K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+5K191031NightOwlEctosense NV20205—
+5K180775Watch-PAT300Itamar Medical, Ltd.201812—
+6K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+6K231546SomfitCompumedics Limited20231—
+6K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+6K213463NightOwlEctosense NV20213—
+6K183559WatchPAT ONEItamar Medical, Ltd.20195—
+7K252383Somfit DCompumedics Limited20250—
+7K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+7K220095ANNE SleepSibel, Inc.20224—
+7K220028NightOwlEctosense NV20222—
+8K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+8K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+8K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+8K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+9K254042WatchPAT SWItamar Medical, Ltd.20260—
+9K244027Sansa HsatHuxley Medical20252—
+10K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+10K252497Sansa HsatHuxley Medical20250—