510(k) Report

Devices descending from K053140

7 later devices reach Ambu Mark IV Resuscitator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102824Ambu Oval Silicone Resuscitator, Adult and PediatricAmbu A/S20110—
+1K092085Ispira Resuscitation UnitNeoforce Group, Inc.20094—
+1K073410Save ResuscitatorArtivent Corporation20080—
+2K142096T-Piece ResuscitatorMercury Medical20140—
+2K110119Pressure ManometerNeoforce Group, Inc.20111—
+2K102649Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc.20112—
+3K122627Gio Digital Pressure GuagesGalemed Corp.20130—