510(k) Report

Devices descending from K111395

13 later devices reach Primewire Prestige Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201720LiPPS Analyzer, LiPPS Wire Pressure Guide WireBeijing Bywave Sensing Medical Technology Co., Ltd.20210—
+1K192340OptoMonitorOpsens, Inc.20197—
+1K161263OptoMonitor IIOpsens, Inc.20160—
+1K142598Opto Wire and OptoMonitor SystemOpsens, Inc.201512—
+2K202943OptoMonitor 3Opsens, Inc.20205—
+2K193620OptoMonitor 3Opsens, Inc.20206—
+2K152991OptoWire DeuxOpsens20166—
+3K213854SavvyWireOpsens, Inc.20224—
+3K191907OptoWire IIIOpsens, Inc.20205—
+4K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.20260—
+4K241418OptoMonitor 3Opsens, Inc.20251—
+4K240864PacePro WireOpsens, Inc.20240—
+5K251367OptoMonitor 3Opsens, Inc.20260—