510(k) Report

Devices descending from K042616

5 later devices reach Biomedix Padnet Lab through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103693Vantage AbiSummit Doppler Systems, Inc.20110—
+1K093205PadcheckPadtest, LLC20100—
+1K073146Padnet+Biomedix, Inc.20072—
+2K122281Padnet 2.0Biomedix, Inc.20121—
+3K220527PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. Biomedix20220—