510(k) Report

Devices descending from K180775

12 later devices reach Watch-PAT300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231546SomfitCompumedics Limited20231—
+1K222331WatchPAT300 (WP300)Itamar Medical, Ltd.20223—
+1K183559WatchPAT ONEItamar Medical, Ltd.20195—
+2K252383Somfit DCompumedics Limited20250—
+2K223675WatchPAT ONE (WP1)Itamar Medical, Ltd.20232—
+2K220095ANNE SleepSibel, Inc.20224—
+3K250460WatchPAT400 (WP400)Itamar Medical, Ltd.20251—
+3K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical20243—
+4K254042WatchPAT SWItamar Medical, Ltd.20260—
+4K244027Sansa HsatHuxley Medical20252—
+5K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express20260—
+5K252497Sansa HsatHuxley Medical20250—