510(k) Report

Devices descending from K012031

13 later devices reach Modification to Thermal Angel through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103801Hypothermx Intravenous Fluid WarmerEmit Corporation20110—
+1K060537Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC…Enginivity, LLC200612Class I
+2K112902Enflow IV Fluid WarmerVital Signs, Inc.201210—
+3K232107°M Warmer SystemMequ A/S20241—
+3K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.20231—
+3K181775Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc.20191—
+3K150404QiF Blood and Fluid WarmerQuality IN Flow, Ltd.20161—
+3K121775Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow ControllerVital Signs, Inc., A GE Healthcare Company20121—
+4K260988°M Warmer System with °M StationMequ A/S20260—
+4K252636Fluido Compact SystemThe Surgical Company International B.V.20250—
+4K192325Quantum Blood and Fluid Warming SystemLife Warmer, Inc.20190—
+4K163708QiF Blood and Fluid WarmerQuality IN Flow, Ltd.20170—
+4K130867Enflow IV Fluid Warmer Insulated StrapVital Signs, Inc., A GE Healthcare Company20130Class I