510(k) Report

Devices descending from K081285

40 later devices reach Finger Pulse Oximeter, Model 9560 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201524—
+1K131021Pulse OximeterNonin Medical, Inc.20133—
+1K113865PultolSharp Corporation20120—
+1K092620MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.200910—
+2K191403Pulse OximeterNonin Medical, Inc.20191—
+2K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation201923—
+2K142888Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20158—
+2K140785Pulse OximeterNonin Medical, Inc.20140—
+2K111494Handheld Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd.20120—
+3K241086Avidhrt Sense SpO2Avidhrt, Inc.20250—
+3K214115MightySat -OTCMasimo Corporation20241—
+3K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd.20225—
+3K211400Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20220—
+3K211632Pulse 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—
+3K202743Med-Link Temp-pulse OximeterShenzhen Med-Link Electronics Tech Co., Ltd.20210—
+3K181352Loop SystemSpry Health, Inc.201910—
+3K181503Fingertip Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20186—
+3K152091Fingertip Pulse OximeterJiangsu Konsung Bio-Medical Science & Technology Co., Ltd.20160—
+4K250837Pulse OximeterShanghai Berry Electronic Tech Co., Ltd.20250—
+4K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.20240—
+4K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.20242—
+4K232975Pulse Oximeter (MD300C228)Beijing Choice Electronic Technology Co., Ltd.20240—
+4K232445CSF-4 (CSF-4)Cardiacsense20240—
+4K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20234—
+4K230172Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20231—
+4K220101Pulse OximeterBeijing Choice Electronic Technology Co., Ltd.20230—
+4K222010Biobeat Platform-2 and BB-613WP PatchBiobeat Technologies, Ltd.20221—
+4K222213Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103…Unimed Medical Supplies, Inc.20220—
+4K221282Empatica Health Monitoring PlatformEmpatica S.r.l.20227—
+4K220351Polso WatchChronisense Medical, Ltd.20220—
+5K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+5K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.20260—
+5K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC20260—
+5K252981EmbraceMiniEmpatica S.r.l.20251—
+5K242737Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l.20250—
+5K241066BB-613-BPMBiobeat Technologies, Ltd.20250—
+5K243049Pulse Oximeter (FS20P); Pulse Oximeter (FS20C); Pulse Oximeter (FS10C)Hunan Accurate Bio-Medical Technology Co., Ltd.20250—
+5K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+5K232915EpiMonitorEmpatica S.r.l.20241—
+6K250515EpiMonitorEmpatica S.r.l.20250—