510(k) Report

Devices descending from K152991

6 later devices reach OptoWire Deux through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191907OptoWire IIIOpsens, Inc.20205—
+2K213854SavvyWireOpsens, Inc.20224—
+3K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.20260—
+3K241418OptoMonitor 3Opsens, Inc.20251—
+3K240864PacePro WireOpsens, Inc.20240—
+4K251367OptoMonitor 3Opsens, Inc.20260—