510(k) Report

Devices descending from K101128

4 later devices reach Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and Premium… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192105Innonix Antiviral Child's Face MaskInnonix Technologies Limited20190—
+1K182766Cufitec Surgical MaskNbc Meshtec, Inc.20190—
+1K122702Biofriend Biomask N95 Surgical RespiratorFilligent Limited20131—
+2K150729SpectraShield 9500 Surgical N95 RespiratorNexera Medical, Inc.20150—