510(k) Report

Devices descending from K161222

6 later devices reach PENTAX MEDICAL ED-3490TK, Video Duodenoscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video DuodenoscopePentax of America, Inc.20185—
+2K192245Pentax Medical Video Duodenoscope ED34-i10T2Pentax of America, Inc.201931
+2K192280PENTAX Medical ED-3490TK Video DuodenoscopePentax Medical20190—
+3K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor…Pentax of America, Inc.20240—
+3K210710PENTAX Medical Video Duedenoscope ED34-i10T2Pentax of America, Inc.202101
+3K202365Pentax Medical Video Duodenoscope ED32-i10Pentax of America, Inc.20210—