510(k) Report

Devices descending from K161579

20 later devices reach Watch-PAT200U through their predicates, nearest generation first.

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