510(k) Report

Devices descending from K003335

18 later devices reach Resuscitaire Radiant Warmer; Resuscitaire Birthing Room Warmer; Resuscitair… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120642Resuscitaire with AutobreathDraeger Medical Systems, Inc.201221
+1K120937Sunflower WarnerAtom Medical Corporation20120—
+1K070247Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical20074Class I
+1K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical200710Class I
+1K020966Rpi Replacement Heating ElementsReplacement Parts Industries, Inc.20020—
+1K021531Rpi Replacement Phototherapy LightsReplacement Parts Industries, Inc.20020—
+2K230278Babyroo TN300Draeger Medical Systems, Inc.20231—
+2K140707Lifeborne Infant ResuscitatorInternational Biomedical20141—
+2K103317Resuscitation Unit 105Atom Medical Corporation20110—
+2K102542Resusci Flow; Resusci Flow 104Atom Medical Corporation20110—
+2K093913Mercury Medical T-Piece ResuscitatorMercury Medical, Inc.20101Class I
+2K070377Giraffe and Panda WarmerOhmeda Medical20073Class I
+3K243606Babyroo TN300Draeger Medical Systems, Inc.20250—
+3K182956Puffin Lite Infant Resuscitation SystemInternational Biomedical20190—
+3K173373SafeT T-Piece ResuscitatorVentlab, LLC20180—
+3K123309Giraffe and Panda WarmersOhmeda Medical20130Class I
+3K090697Modification to: Giraffe and Panda WarmerOhmeda Medical20091Class I
+3K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical200721