510(k) Report

Devices descending from K053645

6 later devices reach Modification to:Bair Hugger Temperature Management Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140635Cocoon Convective Warming SystemCare Essentials Pty, Ltd.201402
+1K060865Bair Paws Temperature Management System Model 850Arizant Healthcare, Inc.200646
+2K232502Cocoon Convective Warming System, Model CWS7000Care Essentials Pty, Ltd.20240—
+2K083336Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1…Smiths Medical Asd, Inc.20092—
+3K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…Smith Medical Asd, Inc.20141—
+4K181699Level 1 Convective WarmerSmiths Medical Asd, Inc.20180—