510(k) Report

Devices descending from K112902

10 later devices reach Enflow IV Fluid Warmer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232107°M Warmer SystemMequ A/S20241—
+1K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.20231—
+1K181775Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc.20191—
+1K150404QiF Blood and Fluid WarmerQuality IN Flow, Ltd.20161—
+1K121775Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow ControllerVital Signs, Inc., A GE Healthcare Company20121—
+2K260988°M Warmer System with °M StationMequ A/S20260—
+2K252636Fluido Compact SystemThe Surgical Company International B.V.20250—
+2K192325Quantum Blood and Fluid Warming SystemLife Warmer, Inc.20190—
+2K163708QiF Blood and Fluid WarmerQuality IN Flow, Ltd.20170—
+2K130867Enflow IV Fluid Warmer Insulated StrapVital Signs, Inc., A GE Healthcare Company20130Class I