510(k) Report

Devices descending from K051182

11 later devices reach Inovel Health Care Model N95 Particulate Respirators and Surgical Masks through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102173Moldex-Metric Health Care N95 Particulate Respirator and Surgical Mask, Model 1712Moldex/Metric, Inc.20100—
+1K070139Willson One-Fit Healthcare Particle Respirator and Surgical Mask, HC-NB095Survivair, Inc.20075—
+1K063747Inovel Health Care N95 Particulate Respirators and Surgical Masks, Models MFRN95-S…Inovel, LLC20070—
+1K062665Inovel Health Care N95 Particulate Respirators and Surgical MasksInovel, LLC20061—
+1K062663Moldex Health Care N95 Particulate Respirators and Surgical MasksMoldex/Metric, Inc.20060—
+1K061859Inovel Health Care N95 Particulate Respirators & Surgical MasksInovel, LLC20063—
+2K141876Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture…Pasture Pharma Pte, Ltd.20150—
+2K070782Willson One-Fit Flat-Fold Healthcare Particulate Respirator and Surgical Mask, Models…Survivair Respirators, LLC20073—
+3K081923Actiprotect UF N95 Respirator, Double Strap, Flat FoldGlaxosmithkline Consumer Healthcare20092—
+4K093189Actiprotect UC N95 RespiratorGlaxosmithkline Consumer Healthcare20100—
+4K093161Actiprotect UF N95 RespiratorGlaxosmithkline Consumer Healthcare20100—