510(k) Report

Devices descending from K070139

5 later devices reach Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141876Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture…Pasture Pharma Pte, Ltd.20150—
+1K070782Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models…Survivair Respirators, LLC20073—
+2K081923Actiprotect UF N95 Respirator, Double Strap, Flat FoldGlaxosmithkline Consumer Healthcare20092—
+3K093189Actiprotect UC N95 RespiratorGlaxosmithkline Consumer Healthcare20100—
+3K093161Actiprotect UF N95 RespiratorGlaxosmithkline Consumer Healthcare20100—