510(k) Report

Devices descending from K061513

3 later devices reach Level 1 Snuggle Warm Pediatric and Large Pediatric Underbody Blanket through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141686Equator Convective Warmer, Snuggle Warm Adult Full Body Convective Warming Blanket…Smith Medical Asd, Inc.20141—
+1K083336Level 1 Snuggle Warm Adult Underbody Convective Warming Blanket, Model SW-2013, Level 1…Smiths Medical Asd, Inc.20092—
+2K181699Level 1 Convective WarmerSmiths Medical Asd, Inc.20180—