510(k) Report

Devices descending from K060537

12 later devices reach Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112902Enflow IV Fluid WarmerVital Signs, Inc.201210—
+1K103801Hypothermx Intravenous Fluid WarmerEmit Corporation20110—
+2K232107°M Warmer SystemMequ A/S20241—
+2K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.20231—
+2K181775Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc.20191—
+2K150404QiF Blood and Fluid WarmerQuality IN Flow, Ltd.20161—
+2K121775Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow ControllerVital Signs, Inc., A GE Healthcare Company20121—
+3K260988°M Warmer System with °M StationMequ A/S20260—
+3K252636Fluido Compact SystemThe Surgical Company International B.V.20250—
+3K192325Quantum Blood and Fluid Warming SystemLife Warmer, Inc.20190—
+3K163708QiF Blood and Fluid WarmerQuality IN Flow, Ltd.20170—
+3K130867Enflow IV Fluid Warmer Insulated StrapVital Signs, Inc., A GE Healthcare Company20130Class I