510(k) Report

Devices descending from K220605

2 later devices reach Venus Bulk Flow ONE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260783Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneKulzer, LLC20260—
+1K250267Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062)…Kettenbach GmbH & Co. KG20250—