510(k) Report

Devices descending from K090414

2 later devices reach Spectrashield 9500 Surgical Mask through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120244Spectrashield 9500 Surgical N95 RespiratorNexera Medical, Inc.20121—
+2K150729SpectraShield 9500 Surgical N95 RespiratorNexera Medical, Inc.20150—