510(k) Report

Devices descending from K023289

17 later devices reach Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090468Hamilton-C2Hamilton Medical AG20090—
+1K040642Lpo Option for Drager Intensive Care Ventilator SavinaDraeget Medical AG & Co. Kgaa200415—
+2K102775Hamilton-C2Hamilton Medical AG201114—
+3K121225Hamilton-C2Hamilton Medical AG20128Class I
+3K112006Hamilton-TC1Hamilton Medical AG201213—
+4K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG201521
+4K123637Hamilton-C3Hamilton Medical AG20124—
+4K120574Hamilton-C1Hamilton Medical AG20123—
+4K120670Hamilton-T1Hamilton Medical AG201211Class I
+5K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG20190Class I
+5K162832731 Series VentilatorsZOLL Medical Corporation20171Class I
+5K161450Hamilton-C3Hamilton Medical AG201732
+5K153046Hamilton-MR1Hamilton Medical AG20160Class I
+6K233486731 Series VentilatorZOLL Medical Corporation20240—
+6K201306Hamilton-C3Hamilton Medical AG20210Class I
+6K201658Hamilton-C6Hamilton Medical AG20201Class I
+7K252663Inbentus VersatileIconic Solutions by Murcia, SL20260—