510(k) Report

Devices descending from K892885

26 later devices reach Resubmitted RD1000 Neopuff Infant Resuscitator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)Draegerwerk AG & CO Kgaa20250—
+1K140707Lifeborne Infant ResuscitatorInternational Biomedical20141—
+1K120642Resuscitaire with AutobreathDraeger Medical Systems, Inc.201221
+1K102542Resusci Flow; Resusci Flow 104Atom Medical Corporation20110—
+1K102649Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc.20112—
+1K093913Mercury Medical T-Piece ResuscitatorMercury Medical, Inc.20101Class I
+1K092085Ispira Resuscitation UnitNeoforce Group, Inc.20094—
+1K072021Neopip Infant ResuscitatorNeoforce Group, Inc.20073—
+1K070416Neopeep Neonatal Resuscitation Circuit with PeepNeoforce Group, Inc.20072—
+1K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical200710Class I
+1K972885Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual Control Wall-Mount…Fisher & Paykel Electronics, Ltd.19970—
+1K971695Servo-Control Cosycot Infant Warmer, Manual-Control Cosycot Infant WarmerFisher & Paykel Electronics, Ltd.19970—
+2K230278Babyroo TN300Draeger Medical Systems, Inc.20231—
+2K182956Puffin Lite Infant Resuscitation SystemInternational Biomedical20190—
+2K173373SafeT T-Piece ResuscitatorVentlab, LLC20180—
+2K142096T-Piece ResuscitatorMercury Medical20140—
+2K110119Pressure ManometerNeoforce Group, Inc.20111—
+2K103317Resuscitation Unit 105Atom Medical Corporation20110—
+2K103833Neopip Patient Circuit with PeepNeoforce Group, Inc.20110—
+2K092029Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310Draeger Medical AG & Co. KG20100Class I
+2K070377Giraffe and Panda WarmerOhmeda Medical20073Class I
+3K243606Babyroo TN300Draeger Medical Systems, Inc.20250—
+3K122627Gio Digital Pressure GuagesGalemed Corp.20130—
+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