510(k) Report

Devices descending from K973314

5 later devices reach Spirosafe Filter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190022SafeBreath Filter MouthpieceMD Diagnostics Limited20190—
+1K121382Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]Westmed, Inc.20120—
+1K051279Caldyne, Inc. Exhalometer EX100, Model EX100Caldyne, Inc.20050—
+1K043148All Flow Pulmonary Function FilterAlliance Tech Medical, Inc.200421
+2K062913Astraguard Pulmonary Function FilterSdi Diagnostics, Inc.20070—