510(k) Report

Devices descending from K181956

23 later devices reach Masimo MightySat Rx Fingertip Pulse Oximeter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+1K214115MightySat -OTCMasimo Corporation20241—
+1K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+1K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+1K211632Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102…Shenzhen Narig Bio-Medical Technology Co., Ltd.20221—
+1K181352Loop SystemSpry Health, Inc.201910—
+2K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+2K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+2K232445CSF-4 (CSF-4)Cardiacsense20240—
+2K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+2K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+2K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+2K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+2K220351Polso WatchChronisense Medical, Ltd.20220—
+3K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+3K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+3K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+3K252981EmbraceMiniEmpatica S.r.l.20251—
+3K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+3K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+3K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+3K232915EpiMonitorEmpatica S.r.l.20241—
+4K250515EpiMonitorEmpatica S.r.l.20250—