510(k) Report

Devices descending from K002622

26 later devices reach Biosleep through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080427Watch-Pat Model 100S-2Itamar Medical200825—
+2K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical200824—
+3K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd.201123—
+4K133859Watch-PAT200U (WP200U)Itamar Medical, Ltd.201422—
+5K161579Watch-PAT200UItamar Medical, Ltd.201720—
+5K153070Watch-PAT200UItamar Medical, Ltd.20160—
+6K203839WatchPAT200U (WP200U)Itamar Medical, Ltd.20224—
+6K191031NightOwlEctosense NV20205—
+6K180775Watch-PAT300Itamar Medical, Ltd.201812—
+7K242224Happy Health Home Sleep TestHappy Health, Inc.20250—
+7K231546SomfitCompumedics Limited20231—
+7K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+7K213463NightOwlEctosense NV20213—
+7K183559WatchPAT ONEItamar Medical, Ltd.20195—
+8K252383Somfit DCompumedics Limited20250—
+8K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+8K220095ANNE SleepSibel, Inc.20224—
+8K220028NightOwlEctosense NV20222—
+9K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+9K243268TipTraQ (TTQ001)Pranaq Pte., Ltd.20250—
+9K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+9K222579Belun Sleep System BLS-100Belun Technology Company Limited20230—
+10K254042WatchPAT SWItamar Medical, Ltd.20260—
+10K244027Sansa HsatHuxley Medical20252—
+11K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+11K252497Sansa HsatHuxley Medical20250—