510(k) Report

Devices descending from K973741

31 later devices reach Bair Hugger Blood/Fluid Warmer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120860Infu Box Type 0412AMedical Rescue Equipment Holding AS20120—
+1K082217Ranger Rapid Flow Blood/Fluid Warming SystemArizant Healthcare, Inc.20081—
+1K060851Soft Sack IV Fluid Warmer, the Floormount IV Fluid Warmer, the Pak 2 IV Warmer and the…The Smithworks Company20061—
+1K060939Ranger Irrigation Fluid Warming SystemArizant Healthcare, Inc.200681
+1K012832Comfortmate Fluid Warming System, Model # FW-200; Comfortmate Disporsable Disposable…Nxstage Medical, Inc.20012—
+1K012031Modification to Thermal AngelEstill Medical Technologies, Inc.2001131
+1K984640Thermal AngelEstill Medical Technologies, Inc.1999161
+2K152946TempedySeiratherm GmbH20160—
+2K103801Hypothermx Intravenous Fluid WarmerEmit Corporation20110—
+2K091939Thermedx Prodigy Fluid Management System, Models P1000, P2000Thermedx, LLC201042
+2K072080Normoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming…Smiths Medical Asd, Inc.20087Class I
+2K071263Nxstage Travel Warmer, Models TW-400 & FWS-500Nxstage Medical, Inc.200711
+2K060537Eflow IV Fluid Warmer, Model 100, Eflow Disposable Cartridge, Model 200 and Eflow AC…Enginivity, LLC200612Class I
+3K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU Medical20260—
+3K172048FluidSmartThermedx, LLC201721
+3K152278ENDOFLOW II - Irrigation, Warming and Suction SystemPromepla Sam20160—
+3K133799Thermedx Fluid Managment SystemThermedx, LLC201432
+3K140623Nxstage Express Fluid WarmerNxstage Medical, Inc.20140—
+3K112902Enflow IV Fluid WarmerVital Signs, Inc.201210—
+4K251273Asurys Fluid Management SystemBoston Scientific Corporation20260—
+4K232107°M Warmer SystemMequ A/S20241—
+4K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.20231—
+4K210628X-FLO Fluid Management SystemThermedx, LLC20210—
+4K181775Quantum Blood and IV Fluid Infusion WarmerLife Warmer, Inc.20191—
+4K150404QiF Blood and Fluid WarmerQuality IN Flow, Ltd.20161—
+4K121775Enflow IV Fluid Warmer, Enflow Disposable Cartridge, Enflow ControllerVital Signs, Inc., A GE Healthcare Company20121—
+5K260988°M Warmer System with °M StationMequ A/S20260—
+5K252636Fluido Compact SystemThe Surgical Company International B.V.20250—
+5K192325Quantum Blood and Fluid Warming SystemLife Warmer, Inc.20190—
+5K163708QiF Blood and Fluid WarmerQuality IN Flow, Ltd.20170—
+5K130867Enflow IV Fluid Warmer Insulated StrapVital Signs, Inc., A GE Healthcare Company20130Class I