510(k) Report

Devices descending from K002355

19 later devices reach Atom Infa Warmer V-505 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070377Giraffe and Panda WarmerOhmeda Medical20073Class I
+1K070247Giraffe and Panda Bag and Mask Resuscitation SystemOhmeda Medical20074Class I
+1K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical200710Class I
+1K061856V-2200 Infant IncubatorAtom Medical, Inc.20064—
+1K060461V-505 Infa WarmerAtom Medical, Inc.20062—
+2K140707Lifeborne Infant ResuscitatorInternational Biomedical20141—
+2K123309Giraffe and Panda WarmersOhmeda Medical20130Class I
+2K103317Resuscitation Unit 105Atom Medical Corporation20110—
+2K102542Resusci Flow; Resusci Flow 104Atom Medical Corporation20110—
+2K102227Infa Warmer IAtom Medical Corporation20110—
+2K102226Dual Incu IAtom Medical Corporation201105
+2K102279INCU IAtom Medical Corporation20100—
+2K102710Neo-Servo IAtom Medical Corporation20101—
+2K093913Mercury Medical T-Piece ResuscitatorMercury Medical, Inc.20101Class I
+2K090697Modification to: Giraffe and Panda WarmerOhmeda Medical20091Class I
+2K072157Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)Ohmeda Medical200721
+3K182956Puffin Lite Infant Resuscitation SystemInternational Biomedical20190—
+3K173373SafeT T-Piece ResuscitatorVentlab, LLC20180—
+3K132543Infant IncubatorBistos Co., Ltd.20140—